updated the correct files after merging the prompt_engineering branch

ft_validation.jsonl

@@ -10,15 +10,15 @@
 {"input": "This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select\n therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.\n ;\n ;\n Inclusion Criteria:\n Dose Escalation:\n - Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who\n have received standard of care therapy or are ineligible to receive such therapy.\n Phase II:\n - Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell\n lung cancer who have received platinum-based chemotherapy regimen and immune\n checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy\n - Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer\n who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy,\n unless patient was ineligible to such therapy.\n All patients:\n - ECOG performance status of 0 or 1.\n - Patients must have a site of disease amenable to biopsy and be a candidate for tumor\n biopsy according to the treating institution's guidelines.\n Exclusion Criteria:\n - Tumors harboring driver mutations that have approved targeted therapies, with the\n exception of KRAS G12C mutations\n - Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of\n groups in Phase II.\n - Active brain metastases, including symptomatic brain metastases or known\n leptomeningeal disease\n - Clinically significant cardiac disease or risk factors at screening\n - Insufficient bone marrow, hepatic or renal function at screening Other\n protocol-defined inclusion/exclusion criteria may apply", "output": {"inclusion_biomarker": [["KRAS G12C"]], "exclusion_biomarker": []}}
 {"input": "In recent years, the goal of stopping drug therapy, also known as treatment-free remission\n (TFR), is emerging as one of the management goals of chronic myeloid leukemia (CML) therapy.\n Because there is no available data on Asian patients with CML undergoing tyrosine kinase\n inhibitor discontinuation (TKI), the investigators plan to recruit chronic phase CML patients\n with deep treatment response and good medical compliance in Taiwan to evaluate the\n feasibility, safety and clinical consequences of TKI discontinuation.\n ;\n ;\n Inclusion Criteria:\n 1. The participant should be an adult (age \u2a7e20 years) with CP-CML.\n 2. The BCR-ABL fusion should be in the form of either e13a2 or e14a2 (p210)\n 3. The participant should not have documented resistance to a 2nd-generation TKI\n (Nilotinib or Dasatinib)\n 4. The participant should have received \u2265 5 years of consecutive treatment with imatinib,\n or \u2265 4 years of consecutive treatment with a 2nd-generation TKI (Nilotinib or\n Dasatinib)\n 5. The participant should have achieved MR4.5 (BCR-ABL \u2a7d0.0032% IS) or undetectable\n disease in the peripheral blood or bone marrow, for \u2265 2 years, which is documented on\n \u2265 4 separate tests performed \u2265 3 months apart.\n 6. Access to a reliable qPCR-based BCR-ABL test with a sensitivity of detecting of at\n least MR4.5.\n Exclusion Criteria:\n 1. After evaluation, the participant is deemed to be ineligible by the investigator of\n this study.\n 2. The participant has no intention to be recruited into this study.", "output": {"inclusion_biomarker": [["BCR-ABL e13a2"], ["BCR-ABL e14a2"]], "exclusion_biomarker": []}}
 {"input": "HS-10376 is an oral, highly selective, small molecular inhibitor of EGFR/HER2 Exon 20\n insertion mutation. This study will evaluate the safety, tolerability, pharmacokinetics and\n clinical activity of HS-10376 in Chinese advanced Non-Small Cell Lung Cancer (NSCLC)\n patients.\n ;\n ;\n Inclusion Criteria:\n 1. Men or women greater than or equal to 18 years\n 2. Locally advanced or metastatic NSCLC patients confirmed by histology or cytology, for\n which standard treatment is invalid, unavailable or intolerable\n 3. Pathological, tumor tissue samples can be used to test EGFR/HER2 Exon 20 insertion\n mutation by central laboratory for subjects\n 4. At least one measurable lesion in accordance with RECIST 1.1\n 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0~1\n 6. Estimated life expectancy >12 weeks\n 7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while\n participating in this study and for a period of 6 months after the last dose.\n Likewise, men also consent to use adequate contraceptive method within the same time\n limit.\n 8. Females must have the evidence of non-childbearing potential\n 9. Signed and dated Informed Consent Form\n Exclusion Criteria:\n 1. Treatment with any of the following:\n - Previous or current treatment with EGFR Exon 20 insertion inhibitors, HER2 Exon\n 20 insertion inhibitors or EGFR/HER2 Exon 20 insertion inhibitors\n - Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small\n molecule inhibitors within 14 days of the first dose of HS-10376\n - Any investigational agents and large molecule antibodies within 28 days of the\n first dose of HS-10376\n - Local radiotherapy for palliation within 2 weeks of the first dose of HS-10376,\n or patients received more than 30% of the bone marrow irradiation, or large-scale\n radiotherapy within 4 weeks of the first dose of HS-10376\n - Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4\n weeks of the first dose of HS-10376\n 2. Inadequate bone marrow reserve or serious organ dysfunction\n 3. Uncontrolled pleural, ascites or pericardial effusion\n 4. Untreated, symptomatic or active central nervous system metastases\n 5. Severe or poorly controlled hypertension\n 6. Immunodeficiency disease and active infectious disease\n 7. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to\n swallow oral medications\n 8. History of hypersensitivity to any active or inactive ingredient of HS-10376 or to\n drugs with a similar chemical structure or drugs belonging to the same category of\n HS-10376\n 9. The subject who is unlikely to comply with study procedures, restrictions, or\n requirements judged by the investigator\n 10. The subject whose safety cannot be ensured or study assessments would be interfered\n judged by the investigator\n 11. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the\n study\n 12. History of neuropathy or mental disorders, including epilepsy and dementia", "output": {"inclusion_biomarker": [["EGFR Exon 20 insertion"], ["HER2 Exon 20 insertion"]], "exclusion_biomarker": []}}
-{"input": "This is a prospective, single arm study to investigate the efficacy and safety furmonertinib\n 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and\n stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary\n endpoint is the disease-free survival rate at 3 years.\n ;NA;\n Inclusion Criteria:\n - Received radical resection of non-small cell lung cancer without prior anti-tumor\n therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.\n - Histologically diagnosed Non-small cell lung cancer based on the judgement of at least\n 2 pathologists.\n - Stage IA with high risk factors including micropapillae or solid components, vascular\n invasion, spread through air spaces, low differentiation, tumor budding and\n insufficient lymph node dissection; Stage IB with or without high-risk factors. The\n pathological stage is based on the 8th edition of AJCC lung cancer staging.\n - EGFR mutation positive according to NGS testing by tissue, including deletions in exon\n 19, L858R, S768I, G719X, L861Q, T790M mutations et al.\n - ECOG performance status 0-1.\n - Sufficient organ function in liver, renal, kidney and hematology.\n - With written signed informed consent form, ability to report adverse events, and good\n adherence to clinical study.\n Exclusion Criteria:\n - Lung cancer with small cell or neuroendocrine cancer cell.\n - EGFR exon 20 insertion positive.\n - Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.\n - Women who are pregnant or breastfeeding.\n - Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days\n prior to initial administration, use of other anti-tumor treatment including\n traditional Chinese medicine within 14 days before enrollment.\n - Concurrent with other malignancies excluding carcinoma in situ.\n - With uncontrolled systematic diseases such as active bleeding, unstable angina, heart\n infarction within 1 year, chronic heart failure and uncontrolled hypertension and\n diabetes mellitus; with active infection of HBV, HCV or HIV, or other infections\n requiring injection of antibiotics.\n - Gastrointestinal disorders which may affect drug taking or absorption.\n - With history of QT prolongation or relative risk factors including heart failure,\n hypokalemia, congenital long QT syndrome, family history of long QT syndrome et al.\n - With history of interstitial lung disease or relative risk.\n - Allergic to any component of furmonertinib tablet.\n - Mental illness or drug abuse.\n - Live vaccination within 30 days before enrollment.\n - Other situation judged by investigator such as failure to follow the rules of study.\n - Attending another study of investigational drug, or received other study drugs or\n medical devices with 4 weeks before enrollment.", "output": {"inclusion_biomarker": [["EGFR mutation"], ["EGFR exon 19 deletion"], ["EGFR L858R"], ["EGFR S768I"], ["EGFR G719X"], ["EGFR L861Q"], ["EGFR T790M"]], "exclusion_biomarker": [["EGFR exon 20 insertion"], ["ALK alteration"], ["ROS1 alteration"], ["MET alteration"]]}}
-{"input": "BRAF mutation exists in about 10-12% of colorectal cancer, among which BRAF V600E mutation is\n the most common type, which is an important biomarker for predicting the prognosis and\n precise treatment efficacy of metastatic colorectal cancer (mCRC). The prognosis of\n metastatic colorectal cancer with BRAF V600E mutation is very poor, with OS of about 6-9\n months. Previous studies have shown that single anti-BRAF inhibitor are ineffective, while\n multi-target inhibitions of Ras-Raf -MEK pathway is a possible effective strategy for BRAF\n V600E-mutant mCRC. Currently, the proven effective regimens include the VIC regimen\n (Vemurafenib + cetuximab + Irinotecan) and BEACON regimen (Encorafenib+ cetuximab +/-\n Binimetinib) from the SWOGS1406 study. Furthermore, BRAF inhibitor +MEK inhibitor combined\n with PD-1 monoclonal antibody has been shown to be an effective strategy in BRAF V600E-mutant\n malignant melanoma, which promote the study of the regimens for the treatment of BRAF\n V600E-mutant mCRC. Increasing basic and clinical studies have shown that cetuximab has ADCC\n effect, induces immunogenic cell death, promotes immune cell infiltration and other\n immunomodulatory effects, and has a synergistic effect with PD-1 monoclonal antibody in\n colorectal cancer. Based on those theories, we conducted the phase I study to explore the\n safety and preliminary efficacy of the regimen of Vemurafenib (BRAFi) plus cetuximab (EGFRi)\n combined with PD-1 monoclonal antibody in BRAF V600E-mutant /MSS type mCRC.\n ;NA;\n Inclusion Criteria:\n 1. Male or female \u2265 18 years of age\n 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n 3. Participants must have histologically or cytologically confirmed diagnosis of\n adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable\n and/or metastatic disease that is measurable according to Response Evaluation Criteria\n in Solid Tumors (RECIST 1.1) criteria\n 4. Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to\n screening and confirmed by central laboratory. And confirmation of MSS or pMMR status\n from immunohistochemistry or PCR or NGS;\n 5. Prior treatment with at least one systemic treatment (chemotherapy or target therapy)\n for mCRC, and prior treatment did not include cetuximab\n 6. Adequate organ and marrow function:\n - \u2460Hemoglobin (Hb) \u2265 90 g/L\uff1bPlatelets (PLT) \u2265 75 x 10^9/L\uff1bNeutrophil \u22651.5 x 10^9/L\n - \u2461Total bilirubin \u2264 1.5 x upper limit of normal (ULN)\uff1bAspartate aminotransferase\n (AST) \u22643 x ULN \uff1bAlanine aminotransferase (ALT) \u22643 x ULN\n - \u2462Serum creatinine \u2264 1.5 x ULN, or calculated creatinine clearance (determined as\n per Cockcroft-Gault) \u2265 50 mL/min at screening\n - \u2463INR, APTT, and PT\u2264 1.5 x ULN\n - \u2464Serum albumin\u2265 28 g/L\n - \u2465ECG showed no evident abnormality\n 7. Written informed consent\n Exclusion Criteria:\n 1. Known hypersensitivity or contraindication to any component of cetuximab or PD-1\n monoclonal antibody or macromolecular protein reagent.\n 2. A history of other malignancies with a disease-free survival of less than 5 years,\n with the following exceptions: adequately treated basal or squamous cell skin cancer,\n carcinoma in-situ of the cervix, and gastrointestinal tumors treated curatively with\n endoscopic mucosectomy;\n 3. Any active autoimmune disease or a history of autoimmune disease\n 4. Use of immunosuppressive medications or glucocorticoid therapy \u22642 weeks prior to entry\n 5. Uncontrolled active infection requiring antibiotics\n 6. Known history of HIV infection or active hepatitis\n 7. Severe complications, including any of the following:\n - \u2460Massive gastrointestinal bleeding, perforation, or gastrointestinal obstruction\n - \u2461Symptomatic heart disease\n - \u2462Uncontrolled diabetes and hypertension\n - \u2463Uncontrolled diarrhea\n 8. Women who are pregnant or lactating and people who do not agree to avoid pregnancy\n 9. Patients with serious psychiatric that may interfere treatment.\n 10. Other conditions which are inappropriate to participate in the study confirmed by\n investigators.", "output": {"inclusion_biomarker": [["BRAF V600E", "MSS", "pMMR"]], "exclusion_biomarker": []}}
+{"input": "This is a prospective, single arm study to investigate the efficacy and safety furmonertinib\n 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and\n stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary\n endpoint is the disease-free survival rate at 3 years.\n ;NA;\n Inclusion Criteria:\n - Received radical resection of non-small cell lung cancer without prior anti-tumor\n therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.\n - Histologically diagnosed Non-small cell lung cancer based on the judgement of at least\n 2 pathologists.\n - Stage IA with high risk factors including micropapillae or solid components, vascular\n invasion, spread through air spaces, low differentiation, tumor budding and\n insufficient lymph node dissection; Stage IB with or without high-risk factors. The\n pathological stage is based on the 8th edition of AJCC lung cancer staging.\n - EGFR mutation positive according to NGS testing by tissue, including deletions in exon\n 19, L858R, S768I, G719X, L861Q, T790M mutations et al.\n - ECOG performance status 0-1.\n - Sufficient organ function in liver, renal, kidney and hematology.\n - With written signed informed consent form, ability to report adverse events, and good\n adherence to clinical study.\n Exclusion Criteria:\n - Lung cancer with small cell or neuroendocrine cancer cell.\n - EGFR exon 20 insertion positive.\n - Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.\n - Women who are pregnant or breastfeeding.\n - Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days\n prior to initial administration, use of other anti-tumor treatment including\n traditional Chinese medicine within 14 days before enrollment.\n - Concurrent with other malignancies excluding carcinoma in situ.\n - With uncontrolled systematic diseases such as active bleeding, unstable angina, heart\n infarction within 1 year, chronic heart failure and uncontrolled hypertension and\n diabetes mellitus; with active infection of HBV, HCV or HIV, or other infections\n requiring injection of antibiotics.\n - Gastrointestinal disorders which may affect drug taking or absorption.\n - With history of QT prolongation or relative risk factors including heart failure,\n hypokalemia, congenital long QT syndrome, family history of long QT syndrome et al.\n - With history of interstitial lung disease or relative risk.\n - Allergic to any component of furmonertinib tablet.\n - Mental illness or drug abuse.\n - Live vaccination within 30 days before enrollment.\n - Other situation judged by investigator such as failure to follow the rules of study.\n - Attending another study of investigational drug, or received other study drugs or\n medical devices with 4 weeks before enrollment.", "output": {"inclusion_biomarker": [["EGFR mutation"], ["EGFR exon 19 deletion"], ["EGFR L858R"], ["EGFR S768I"], ["EGFR G719X"], ["EGFR L861Q"], ["EGFR T790M"]], "exclusion_biomarker": [["EGFR exon 20 insertion", "ALK alteration"], ["EGFR exon 20 insertion", "ROS1 alteration"], ["EGFR exon 20 insertion", "MET alteration"]]}}
+{"input": "BRAF mutation exists in about 10-12% of colorectal cancer, among which BRAF V600E mutation is\n the most common type, which is an important biomarker for predicting the prognosis and\n precise treatment efficacy of metastatic colorectal cancer (mCRC). The prognosis of\n metastatic colorectal cancer with BRAF V600E mutation is very poor, with OS of about 6-9\n months. Previous studies have shown that single anti-BRAF inhibitor are ineffective, while\n multi-target inhibitions of Ras-Raf -MEK pathway is a possible effective strategy for BRAF\n V600E-mutant mCRC. Currently, the proven effective regimens include the VIC regimen\n (Vemurafenib + cetuximab + Irinotecan) and BEACON regimen (Encorafenib+ cetuximab +/-\n Binimetinib) from the SWOGS1406 study. Furthermore, BRAF inhibitor +MEK inhibitor combined\n with PD-1 monoclonal antibody has been shown to be an effective strategy in BRAF V600E-mutant\n malignant melanoma, which promote the study of the regimens for the treatment of BRAF\n V600E-mutant mCRC. Increasing basic and clinical studies have shown that cetuximab has ADCC\n effect, induces immunogenic cell death, promotes immune cell infiltration and other\n immunomodulatory effects, and has a synergistic effect with PD-1 monoclonal antibody in\n colorectal cancer. Based on those theories, we conducted the phase I study to explore the\n safety and preliminary efficacy of the regimen of Vemurafenib (BRAFi) plus cetuximab (EGFRi)\n combined with PD-1 monoclonal antibody in BRAF V600E-mutant /MSS type mCRC.\n ;NA;\n Inclusion Criteria:\n 1. Male or female \u2265 18 years of age\n 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n 3. Participants must have histologically or cytologically confirmed diagnosis of\n adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable\n and/or metastatic disease that is measurable according to Response Evaluation Criteria\n in Solid Tumors (RECIST 1.1) criteria\n 4. Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to\n screening and confirmed by central laboratory. And confirmation of MSS or pMMR status\n from immunohistochemistry or PCR or NGS;\n 5. Prior treatment with at least one systemic treatment (chemotherapy or target therapy)\n for mCRC, and prior treatment did not include cetuximab\n 6. Adequate organ and marrow function:\n - \u2460Hemoglobin (Hb) \u2265 90 g/L\uff1bPlatelets (PLT) \u2265 75 x 10^9/L\uff1bNeutrophil \u22651.5 x 10^9/L\n - \u2461Total bilirubin \u2264 1.5 x upper limit of normal (ULN)\uff1bAspartate aminotransferase\n (AST) \u22643 x ULN \uff1bAlanine aminotransferase (ALT) \u22643 x ULN\n - \u2462Serum creatinine \u2264 1.5 x ULN, or calculated creatinine clearance (determined as\n per Cockcroft-Gault) \u2265 50 mL/min at screening\n - \u2463INR, APTT, and PT\u2264 1.5 x ULN\n - \u2464Serum albumin\u2265 28 g/L\n - \u2465ECG showed no evident abnormality\n 7. Written informed consent\n Exclusion Criteria:\n 1. Known hypersensitivity or contraindication to any component of cetuximab or PD-1\n monoclonal antibody or macromolecular protein reagent.\n 2. A history of other malignancies with a disease-free survival of less than 5 years,\n with the following exceptions: adequately treated basal or squamous cell skin cancer,\n carcinoma in-situ of the cervix, and gastrointestinal tumors treated curatively with\n endoscopic mucosectomy;\n 3. Any active autoimmune disease or a history of autoimmune disease\n 4. Use of immunosuppressive medications or glucocorticoid therapy \u22642 weeks prior to entry\n 5. Uncontrolled active infection requiring antibiotics\n 6. Known history of HIV infection or active hepatitis\n 7. Severe complications, including any of the following:\n - \u2460Massive gastrointestinal bleeding, perforation, or gastrointestinal obstruction\n - \u2461Symptomatic heart disease\n - \u2462Uncontrolled diabetes and hypertension\n - \u2463Uncontrolled diarrhea\n 8. Women who are pregnant or lactating and people who do not agree to avoid pregnancy\n 9. Patients with serious psychiatric that may interfere treatment.\n 10. Other conditions which are inappropriate to participate in the study confirmed by\n investigators.", "output": {"inclusion_biomarker": [["BRAF V600E", "MSS"], ["BRAF V600E", "pMMR"]], "exclusion_biomarker": []}}
 {"input": "Positron emission tomography (PET) molecular imaging provides a valuable tool for the\n diagnosis and differential diagnosis, staging of various tumors. Malignant tumor is composed\n of tumor cells and tumor stroma, which occupies the vast majority of the tumor.\n Cancer-associated fibroblasts (CAF) are an important part of the tumor stroma. Fibroblast\n activation protein (FAP) is over-expressed in CAF, which is closely related to tumor growth,\n invasion, metastasis, immunosuppression and prognosis; and the expression level of FAP in\n normal tissues and organs is very low. So it becomes an excellent target for cancer diagnosis\n and treatment. Radionuclide-labeled fibroblast activation protein inhibitors (FAPI) that\n specifically target to FAP as a tracer for PET imaging can be applied for targeted diagnosis\n and treatment of cancer. Recently, some studies have found that gallium-68 (68Ga) -FAPI as a\n new novel positron tracer has shown to be with good application potential. In this\n prospective study, the investigators will use integrated PET/MR, and PET/CT with the agent\n 68Ga-FAPI and conventional imaging agent [F-18] fluorodeoxyglucose (18F-FDG) to diagnose and\n stage various cancers, the aim is to make up for the deficiency in FDG PET imaging in the\n diagnosis and staging of some cancers.\n ;\n ;\n Inclusion Criteria:\n - Patients with suspected or diagnosed or treated malignant tumors who have completed\n 18F-FDG PET/CT imaging.\n - Subjects are able to understand and sign the informed consent voluntarily, with good\n compliance.\n Exclusion Criteria:\n - Acute systemic diseases and electrolyte disorders.\n - Pregnant or lactating women.\n - Patients refuse to sign the informed consent.", "output": {"inclusion_biomarker": [], "exclusion_biomarker": []}}
-{"input": "The purpose of this study is to examine the combination of osimertinib and carotuximab to\n assess the safety and find the recommended dose for treatment of advanced EGFR-mutated\n non-small cell lung cancer (NSCLC). Safety and tolerability will be measured by the number of\n dose-limiting toxicities, according to National Cancer Institute Common Toxicity Criteria for\n Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary\n objectives include evaluating the rate of objective response rate, duration of response,\n progression-free survival, and disease control rate, along with assessing biomarkers through\n tumor tissue and circulating tumor DNA.\n ;NA;\n Inclusion Criteria:\n - Stage IV or recurrent/metastatic non-squamous NSCLC that harbors an EGFR activating\n mutation (Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, etc). Local\n testing for EGFR mutations is acceptable provided it was performed in a CLIA certified\n lab.\n - Part I: Progressive disease on at least one prior EGFR TKI\n - Part II, Cohort 1: Progressive disease on osimertinib or other prior EGFR TKIs\n - Part II, Cohort 2: Receiving osimertinib as front line treatment for less than 12\n weeks. Persistent ctDNA with EGFR mutation between weeks 6-12 from the start of\n osimertinib treatment.\n - Age at least 18\n - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2\n - Archival tissue from a biopsy performed after progression of disease on previous EGFR\n TKI or willing to consent for a fresh tumor biopsy.\n - Measurable disease by RECIST 1.1.\n - Patients with untreated brain metastases are allowed provided that the patient is\n clinically asymptomatic and stable.\n - Patients must have completed prior chemotherapy \u2265 3 weeks or radiotherapy \u2265 2 weeks\n prior to receiving study drugs.\n - If the subject's most recent line of therapy is treatment with osimertinib, then all\n adverse events must be resolved to Grade 2 or better\n - If the subject's most recent line of therapy is any other treatment than osimertinib,\n then all Adverse Events must be resolved to grade 1 or better, with the exception of\n fatigue, alopecia and neuropathy (which must resolve to CTCAE grade 2).\n - Adequate organ function\n - Women of childbearing potential and men must agree to use adequate contraception while\n on study.\n - Written informed consent obtained from subject and ability for subject to comply with\n the requirements of the study.\n Exclusion Criteria:\n - Past medical history of interstitial lung disease, drug-induced interstitial lung\n disease, radiation pneumonitis requiring steroid treatment, or any evidence of\n clinically active interstitial lung disease.\n - Small cell lung cancer histology.\n - Other prior malignancy that might interfere with study endpoints per opinion of the\n investigator.\n - Prior exposure to carotuximab or any CD105 targeted antibody.\n - Any major surgical procedure within 2 weeks of starting therapy.\n - Patients must not have a history of uncontrolled or poorly-controlled hypertension\n defined as SBP > 150 mmHg or DBP > 90 mmHg within 28 days prior to enrollment.\n - Active bleeding or pathologic conditions that carries a high bleeding risk (e.g.\n gastric ulcers).\n - Use of thrombolytics within 10 days prior to the first day of carotuximab.\n - Known hypersensitivity to Chinese hamster ovary products or other recombinant human,\n chimeric, or humanized antibodies.\n - A known diagnosis of Osler-Weber-Rendu syndrome.\n - Ascites or pericardial or pleural effusion requiring external drainage procedures.\n - New evidence of leptomeningeal disease.\n - Acute cardiovascular event within the past 6 months.\n - Pregnancy or breastfeeding.", "output": {"inclusion_biomarker": [["EGFR mutation"], ["EGFR Exon 21 L858R"], ["EGFR Exon 19 deletion"], ["EGFR Exon 18 G719X"], ["EGFR Exon 21 L861Q"]], "exclusion_biomarker": []}}
+{"input": "The purpose of this study is to examine the combination of osimertinib and carotuximab to\n assess the safety and find the recommended dose for treatment of advanced EGFR-mutated\n non-small cell lung cancer (NSCLC). Safety and tolerability will be measured by the number of\n dose-limiting toxicities, according to National Cancer Institute Common Toxicity Criteria for\n Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary\n objectives include evaluating the rate of objective response rate, duration of response,\n progression-free survival, and disease control rate, along with assessing biomarkers through\n tumor tissue and circulating tumor DNA.\n ;NA;\n Inclusion Criteria:\n - Stage IV or recurrent/metastatic non-squamous NSCLC that harbors an EGFR activating\n mutation (Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, etc). Local\n testing for EGFR mutations is acceptable provided it was performed in a CLIA certified\n lab.\n - Part I: Progressive disease on at least one prior EGFR TKI\n - Part II, Cohort 1: Progressive disease on osimertinib or other prior EGFR TKIs\n - Part II, Cohort 2: Receiving osimertinib as front line treatment for less than 12\n weeks. Persistent ctDNA with EGFR mutation between weeks 6-12 from the start of\n osimertinib treatment.\n - Age at least 18\n - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2\n - Archival tissue from a biopsy performed after progression of disease on previous EGFR\n TKI or willing to consent for a fresh tumor biopsy.\n - Measurable disease by RECIST 1.1.\n - Patients with untreated brain metastases are allowed provided that the patient is\n clinically asymptomatic and stable.\n - Patients must have completed prior chemotherapy \u2265 3 weeks or radiotherapy \u2265 2 weeks\n prior to receiving study drugs.\n - If the subject's most recent line of therapy is treatment with osimertinib, then all\n adverse events must be resolved to Grade 2 or better\n - If the subject's most recent line of therapy is any other treatment than osimertinib,\n then all Adverse Events must be resolved to grade 1 or better, with the exception of\n fatigue, alopecia and neuropathy (which must resolve to CTCAE grade 2).\n - Adequate organ function\n - Women of childbearing potential and men must agree to use adequate contraception while\n on study.\n - Written informed consent obtained from subject and ability for subject to comply with\n the requirements of the study.\n Exclusion Criteria:\n - Past medical history of interstitial lung disease, drug-induced interstitial lung\n disease, radiation pneumonitis requiring steroid treatment, or any evidence of\n clinically active interstitial lung disease.\n - Small cell lung cancer histology.\n - Other prior malignancy that might interfere with study endpoints per opinion of the\n investigator.\n - Prior exposure to carotuximab or any CD105 targeted antibody.\n - Any major surgical procedure within 2 weeks of starting therapy.\n - Patients must not have a history of uncontrolled or poorly-controlled hypertension\n defined as SBP > 150 mmHg or DBP > 90 mmHg within 28 days prior to enrollment.\n - Active bleeding or pathologic conditions that carries a high bleeding risk (e.g.\n gastric ulcers).\n - Use of thrombolytics within 10 days prior to the first day of carotuximab.\n - Known hypersensitivity to Chinese hamster ovary products or other recombinant human,\n chimeric, or humanized antibodies.\n - A known diagnosis of Osler-Weber-Rendu syndrome.\n - Ascites or pericardial or pleural effusion requiring external drainage procedures.\n - New evidence of leptomeningeal disease.\n - Acute cardiovascular event within the past 6 months.\n - Pregnancy or breastfeeding.", "output": {"inclusion_biomarker": [["EGFR activating mutation"], ["EGFR Exon 21 L858R"], ["EGFR Exon 19 deletion"], ["EGFR Exon 18 G719X"], ["EGFR Exon 21 L861Q"], ["EGFR mutation"]], "exclusion_biomarker": []}}
 {"input": "This is a FIH, phase I/II, open label, multi-center study of DYP688 as a single agent. The\n purpose of this study is to characterize the safety, tolerability, and anti-tumor activity of\n DYP688 as a single agent in patients with metastatic uveal melanoma (MUM) and other melanomas\n harboring GNAQ/11 mutations.\n ;\n ;\n Inclusion Criteria:\n - Patients in the dose escalation part must be \u2265 18 years of age at the time of informed\n consent (ICF) signature. In the phase II part, patients \u2265 12 years of age at the time\n of informed consent may be eligible for enrollment (not applicable in countries where\n enrollment is restricted by the local health authority to patients \u2265 18 years of age).\n Patients must have a minimum weight of 40 kg.\n - ECOG performance status \u2264 1 for patients \u2265 18 years of age; Karnofsky performance\n status \u2265 70 for patients \u2265 16 and < 18 years of age; Lansky performance status \u2265 70\n for patients \u2265 12 and < 16 years of age\n - Patients must be suitable and willing to undergo study required biopsies according to\n the treating institution's own guidelines and requirements. If a biopsy is not\n medically feasible, exceptions may be considered after documented discussion with\n Novartis.\n For all patients in Dose Escalation\n - MUM: uveal melanoma with histologically or cytologically confirmed metastatic disease.\n Patient must be either treatment naive or have received any number of prior lines and\n progressed on most recent therapy\n - Non-MUM: advanced cutaneous or mucosal melanoma with histologically or cytologically\n confirmed metastatic disease that has progressed following all standard therapies or\n that has no satisfactory alternative therapies and has evidence of GNAQ/11 mutation\n based on local data\n For patients in Phase II\n - Tebentafusp na\u00efve group: Diagnosis of uveal melanoma with histologically or\n cytologically confirmed metastatic disease that has progressed following standard\n therapies or that has no satisfactory alternative therapies\n - Tebentafusp pre-treated group: Diagnosis of uveal melanoma with histologically or\n cytologically confirmed metastatic disease. Patients must be previously treated with\n tebentafusp and have progressed\n - Non-MUM: patients with diagnosis of cutaneous or mucosal melanomas harboring GNAQ/11\n mutations based on local data, with histologically or cytologically confirmed\n metastatic disease that has progressed following all standard therapies or that has no\n satisfactory alternative therapies\n Exclusion Criteria:\n - Malignant disease, other than that being treated in this study.\n - Active brain metastases, i.e. symptomatic brain metastases or known leptomeningeal\n disease.\n - Evidence of active bleeding or bleeding diathesis or significant coagulopathy\n (including familial) or a medical condition requiring long term systemic\n anticoagulation that would interfere with biopsies.\n - History of anaphylactic or other severe hypersensitivity / infusion reactions to ADCs\n or monoclonal antibodies, which in the opinion of the investigator may pose an\n increased risk of serious infusion reaction.\n - Treatment with any of the following anti-cancer therapies prior to the first dose of\n study treatment within the stated timeframes:\n - 2 weeks for fluoropyrimidine therapy\n - 4 weeks for radiation therapy or limited field radiation for palliation within \u2264\n 2 weeks prior to the first dose of study treatment.\n - 4 weeks or \u2264 5 half-lives (whichever is shorter) for chemotherapy or biological\n therapy (including monoclonal antibodies) or continuous or intermittent small\n molecule therapeutics or any other investigational agent.\n - 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosoureas\n and mitomycin C.\n - 4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1 antagonists.\n - Clinically significant and / or uncontrolled heart disease such as congestive heart\n failure requiring treatment (NYHA grade \u2265 2) or clinically significant arrhythmia\n despite medical treatment.\n Other protocol-defined inclusion/exclusion criteria may apply.", "output": {"inclusion_biomarker": [["GNAQ mutation"], ["GNA11 mutation"]], "exclusion_biomarker": []}}
 {"input": "It is often impossible to find therapeutic target in intermediate-risk AML, so it is very\n important to select appropriate chemotherapy protocol to eliminate minimal residual disease\n (MRD) in these AML patients. Recent studies demonstrated that leukemia microenvironment is\n the shelter nich for leukemia stem cells and the essential reason for impossibly eliminating\n MRD. Demethylation drug not only prove the effect of chemotherapy, but also change leukemia\n microenvironment through epigenetics modification. Both of them will result in eliminating\n MRD in patients with AML. The investigators designed a multicenter randomized control\n clinical trail to evaluate the effect of demethylation drug combined with chemotherapy in AML\n patients with intermediate-risk factors after hematological complete remission. Efficacy will\n be evaluated through MRD detected by flow cytometry every 1 month. Continuous negative MRD\n indicates a good prognosis. The patients with continuous negative MRD can select auto-HSCT or\n consolidation chemotherapy, those with continuous positive MRD should be considered as\n candidates of allo-HSCT. Overall survival and relapse free survival will be recorded after\n follow-up every 3 months. It will provide a basis for precision therapy and a new way for\n designing a novel protocol for intermediate-risk AML. This clinical trail will benefit to the\n AML patients with intermediate-risk factors.\n ;NA;\n Inclusion Criteria:\n - AML patients with normal heart, lung, liver and renal function, or without serious\n infection. ECOG score is below 2\n Exclusion Criteria:\n - AML patients with abnormal heart, lung, liver and renal function, or with serious\n infection. ECOG score is over 2", "output": {"inclusion_biomarker": [], "exclusion_biomarker": []}}
 {"input": "This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+\n hematologic malignancies.\n ;\n ;\n Selected Inclusion Criteria:\n 1. Histologically confirmed relapsed/refractory hematologic malignancies, including\n Chronic Lymphocytic Lymphoma (CLL/SLL) and selected Non-Hodgkin's Lymphoma (NHL)\n 2. Prior or current documentation of CD19 expression or high likelihood of CD19\n expression based on disease histology\n 3. No signs of symptoms of central nervous system (CNS) disease or detectable evidence of\n CNS or meningeal disease on magnetic resonance imaging (MRI) at the time of screening\n Selected Exclusion Criteria:\n 1. Prior CD19 directed therapy including CD19 CARTs\n 2. Prior allogeneic hematopoietic stem cell transplant within 6 months of enrollment\n 3. Prior autologous hematopoietic stem cell transplant within 6 weeks of enrollment.\n 4. Presence of GVHD", "output": {"inclusion_biomarker": [["CD19 expression"]], "exclusion_biomarker": []}}
 {"input": "Selitrectinib expanded access is for minor and adult patients with cancer having a change in\n a particular gene (NTRK1, NTRK2, or NTRK3 gene fusion). The patients are ineligible for an\n ongoing selitrectinib clinical trial or have other considerations that prevent access to\n selitrectinib through an existing clinical trial. Expanded access is intended to treat\n individual patients with different types of cancers with a NTRK gene fusion, including blood\n cancers, who have previously received tropomyosin receptor kinase (TRK) inhibitor therapy.\n ;NA;\n Inclusion Criteria:\n - Diagnosis of cancer with a NTRK1, NTRK2, and NTRK3 gene fusion\n - Previous treatment with a kinase inhibitor with known activity on TRK inhibition\n - Unable to participate in an ongoing selitrectinib clinical trial\n - Medically suitable for treatment with selitrectinib\n Exclusion Criteria:\n - Currently enrolled in an ongoing clinical study with a TRK inhibitor", "output": {"inclusion_biomarker": [["NTRK1 fusion"], ["NTRK2 fusion"], ["NTRK3 fusion"]], "exclusion_biomarker": []}}
-{"input": "This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination\n with nivolumab in patients with metastatic or advanced epithelial tumours.\n To characterize the safety and tolerability of NG-641 in combination with nivolumab in\n patients with metastatic or advanced epithelial tumours and to determine the recommended dose\n of NG-641 in combination with nivolumab for further development in patients with metastatic\n or advanced epithelial tumours\n ;\n ;\n Inclusion Criteria:\n - Provide written informed consent to participate\n - Patients must have one of eleven histologically or cytologically confirmed\n metastatic/advanced carcinoma or adenocarcinoma that has progressed after at least one\n line of systemic therapy and are incurable by local therapy (contact Sponsor for more\n details regarding the tumour types)\n a. Tumour types included are: urothelial carcinoma, squamous cell carcinoma of the\n head and neck (SCCHN), microsatellite instability (MSI)-high/deficient mismatch repair\n (dMMR) cancer, non-small cell lung cancer (NSCLC), uterine/endometrial cancer,\n cervical cancer, oesophageal cancer, gastric cancer, triple-negative breast cancer\n (TNBC), cutaneous squamous cell carcinoma and hepatocellular carcinoma\n - At least one measurable site of disease according to RECIST Version 1.1 criteria; this\n lesion must be either (i) outside a previously irradiated area or (ii) progressive if\n it is in a previously irradiated area\n - Prior treatment with a PD-1/PD-L1 inhibitor (prior PD-1/PD-L1 may have been given as\n monotherapy or combination therapy)\n - Tumour accessible for biopsy\n - Aged 18 years or over\n - ECOG performance status 0 or 1\n - Predicted life expectancy of \u22656 months\n - Adequate lung reserve (Oxygen saturation on ambient air at sea level \u226595% or the\n equivalent based on altitude (i.e. \u226590% at 5000 feet))\n - Adequate renal function:\n 1. Creatinine \u22641.5 \u00d7 upper limit of normal (ULN) and estimated glomerular filtration\n rate (eGFR) \u226560 mL/minute/1.73m2 (or measured creatinine clearance \u226560 mL/minute)\n 2. Spot albumin-to-creatinine ratio (ACR) for proteinuria at screening and baseline\n \u226430 mg/g. Patients with a spot ACR >30 mg/g who undergo a subsequent 24-hour\n urinary protein test with a result of <1 g/24 h may be included\n - Adequate hepatic function:\n 1. Serum total bilirubin \u22641.5 \u00d7 ULN OR direct bilirubin \u22641 \u00d7 ULN\n 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \u22643 \u00d7 ULN\n range\n 3. Albumin \u22653 g/dL\n - Adequate bone marrow function:\n 1. Absolute neutrophil count \u22651.5 \u00d7 109/L\n 2. Platelets \u2265100 \u00d7 109/L\n 3. Haemoglobin \u226590 g/L (9 g/dL)\n - Coagulation profile within the normal range\n - Meeting reproductive status requirements:\n 1. Must not be pregnant or breastfeeding\n 2. Female patients of childbearing potential, must have a negative serum or urine\n pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human\n chorionic gonadotrophin) within 24 hours before the first dose of study treatment\n 3. Female patients of childbearing potential who are heterosexually active must\n agree to use a highly effective method of contraception to prevent pregnancy, for\n the duration of study treatment and 6 months following the last dose of study\n treatment. Female patients who are continuously not heterosexually active are\n exempt from contraceptive requirements, but must still undergo pregnancy testing\n 4. Female patients who are heterosexually active, irrespective of childbearing\n status, must ensure their male partner agrees to use a condom with spermicide\n during sexual intercourse for the duration of study treatment and 6 months\n following the last dose of study treatment\n 5. Patients must be willing to refrain from egg donation during treatment and for at\n least 6 months following the last dose of study treatment\n 6. Male patients who are sexually active with men or women must agree to use a\n condom with spermicide during intercourse for the duration of study treatment and\n 6 months following the last dose of study treatment. In addition, patients must\n be willing to refrain from sperm donation during this time.\n - Exclusion Criteria:\n - Prior or planned allogeneic or autologous bone marrow or organ transplantation\n - Splenectomy\n - Active infections requiring antibiotics, physician monitoring or systemic therapy\n within 1 week of the anticipated first dose of study drug, or recurrent fevers\n (>38.0\u02daC) associated with a clinical diagnosis of active infection\n - Treatment with the antiviral agents: ribavirin, adefovir, lamivudine or cidofovir\n within 10 days prior to the first dose of study treatment; or pegylated interferon in\n the 4 weeks before the first dose of study treatment\n - Active viral disease or positive test for hepatitis B virus using hepatitis B surface\n antigen test or positive test for HCV using HCV ribonucleic acid (RNA) or HCV antibody\n test indicating acute or chronic infection. Positive test for HIV or AIDS\n - Patients who have active, known or suspected autoimmune disease that has required\n systemic therapy in the past 2 years, are immunocompromised in the opinion of the\n Investigator, or are receiving systemic immunosuppressive treatment\n a. Patients with vitiligo, type I diabetes mellitus, asthma/atopy, residual\n hypothyroidism due to autoimmune disease (which only requires hormone replacement\n therapy), or conditions not expected to recur in the absence of an external trigger\n are permitted to enrol providing they comply with the other eligibility criteria\n relating to renal function. Use of inhaled corticosteroids, local steroid injection,\n or steroid eye drops is allowed\n - Treatment with any live, live-attenuated or COVID-19 vaccine in the 30 days before the\n first dose of NG-641 or nivolumab (COVID-19 vaccines known not to be\n live/live-attenuated or based on an adenoviral vector (e.g. mRNA vaccines) are not\n subject to the 30-day exclusion)\n - Treatment with any other vaccine (including known non-live/live-attenuated and\n non-adenoviral COVID-19 vaccines) in the 7 days before the first dose of NG-641\n - History of prior Grade 3-4 acute kidney injury or other clinically significant renal\n impairment\n - History of clinically significant interstitial lung disease or non-infectious\n pneumonitis\n - Lymphangitic carcinomatosis (clinically suspected or radiographic evidence)\n - Infectious or inflammatory bowel disease in the 3 months before the first dose of\n study treatment\n - Myocardial infarction, stroke or other significant cardiovascular or cerebrovascular\n event in the 12 months before the first dose of study treatment\n - Pulmonary embolism, deep vein thrombosis, or other uncontrolled thromboembolic event\n in the 12 months before the first dose of study treatment, or current treatment with\n therapeutic or prophylactic anticoagulation therapy\n - Grade 3 or 4 gastrointestinal bleeding (or risk factors for gastrointestinal bleeding)\n or haemoptysis in the 3 months before first dose of study treatment, or any history of\n bleeding requiring an investigative procedure (e.g. endoscopy), transfusion or\n hospitalisation in the 12 months before the first dose of study treatment\n - Tumour location/extent considered by the Investigator to present a significant risk if\n tumour flare or necrosis were to occur (e.g. an initial increase in tumour size that\n may lead to intestinal, airway or ureter obstruction, or penetrating tumour\n infiltration of major blood vessels, or other hollow organs potentially at risk of\n perforation)\n - Use of the following prior therapies/treatments:\n 1. Treatment with any other enadenotucirev-based virus (parent virus or\n transgene-modified variants), or fibroblast activation protein (FAP) targeting\n agent at any time\n 2. Treatment with an investigational or licensed anti-cancer monoclonal antibody\n (mAb), immune checkpoint inhibitor, immune stimulatory treatment or other\n biological therapy in the 28 days prior to the first dose of study treatment.\n - Prior anti-PD-1/PD-L1 therapy is permitted without a 'washout' phase c. Treatment with\n an investigational or licensed chemotherapy, targeted small molecule or other\n investigational drug in the 14 days or five half-lives (whichever is shorter) before\n the first dose of study treatment d. Major surgery in the 28 days before the first\n dose of study treatment e. Radiation therapy in the 14 days before the first dose of\n study treatment f. Treatment with complementary medications (e.g. herbal supplements\n or traditional Chinese medicines) to treat the disease under study within the 14 days\n prior to first study treatment. Such medications are permitted if they are used as\n supportive care g. Bisphosphonate therapy or treatment with Receptor Activator of\n Nuclear factor Kappa-\u0392 (RANK)-ligand inhibitors for metastatic bone disease is\n permitted\n - All toxicities attributed to prior anti-cancer therapy (including radiation therapy)\n other than alopecia must have resolved to Grade 1 or baseline before the first dose of\n study treatment\n - Known allergy or hypersensitivity (Grade \u22653) to NG-641 transgene, immune checkpoint\n inhibitor products or formulation, or other monoclonal antibodies\n - Discontinuation from prior treatment with an immune therapy due to a Grade \u22653\n immune-related AE, or any history of life-threatening toxicity related to prior immune\n therapy\n - Other prior malignancy active within the previous 3 years, except for local or organ\n confined early stage cancer that has been definitively treated with curative intent,\n does not require ongoing treatment, has no evidence of residual disease and has a\n negligible risk of recurrence and is therefore unlikely to interfere with the primary\n and secondary endpoints of the study, including response rate and safety\n - Symptomatic brain metastases or any leptomeningeal metastases that are symptomatic\n and/or requires treatment\n - Any serious or uncontrolled medical disorder that, in the opinion of the Investigator\n or the Medical Monitor, may increase the risk associated with study participation or\n study treatment administration, impair the ability of the patient to receive protocol\n therapy or interfere with the interpretation of study results", "output": {"inclusion_biomarker": [], "exclusion_biomarker": []}}
+{"input": "This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination\n with nivolumab in patients with metastatic or advanced epithelial tumours.\n To characterize the safety and tolerability of NG-641 in combination with nivolumab in\n patients with metastatic or advanced epithelial tumours and to determine the recommended dose\n of NG-641 in combination with nivolumab for further development in patients with metastatic\n or advanced epithelial tumours\n ;\n ;\n Inclusion Criteria:\n - Provide written informed consent to participate\n - Patients must have one of eleven histologically or cytologically confirmed\n metastatic/advanced carcinoma or adenocarcinoma that has progressed after at least one\n line of systemic therapy and are incurable by local therapy (contact Sponsor for more\n details regarding the tumour types)\n a. Tumour types included are: urothelial carcinoma, squamous cell carcinoma of the\n head and neck (SCCHN), microsatellite instability (MSI)-high/deficient mismatch repair\n (dMMR) cancer, non-small cell lung cancer (NSCLC), uterine/endometrial cancer,\n cervical cancer, oesophageal cancer, gastric cancer, triple-negative breast cancer\n (TNBC), cutaneous squamous cell carcinoma and hepatocellular carcinoma\n - At least one measurable site of disease according to RECIST Version 1.1 criteria; this\n lesion must be either (i) outside a previously irradiated area or (ii) progressive if\n it is in a previously irradiated area\n - Prior treatment with a PD-1/PD-L1 inhibitor (prior PD-1/PD-L1 may have been given as\n monotherapy or combination therapy)\n - Tumour accessible for biopsy\n - Aged 18 years or over\n - ECOG performance status 0 or 1\n - Predicted life expectancy of \u22656 months\n - Adequate lung reserve (Oxygen saturation on ambient air at sea level \u226595% or the\n equivalent based on altitude (i.e. \u226590% at 5000 feet))\n - Adequate renal function:\n 1. Creatinine \u22641.5 \u00d7 upper limit of normal (ULN) and estimated glomerular filtration\n rate (eGFR) \u226560 mL/minute/1.73m2 (or measured creatinine clearance \u226560 mL/minute)\n 2. Spot albumin-to-creatinine ratio (ACR) for proteinuria at screening and baseline\n \u226430 mg/g. Patients with a spot ACR >30 mg/g who undergo a subsequent 24-hour\n urinary protein test with a result of <1 g/24 h may be included\n - Adequate hepatic function:\n 1. Serum total bilirubin \u22641.5 \u00d7 ULN OR direct bilirubin \u22641 \u00d7 ULN\n 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \u22643 \u00d7 ULN\n range\n 3. Albumin \u22653 g/dL\n - Adequate bone marrow function:\n 1. Absolute neutrophil count \u22651.5 \u00d7 109/L\n 2. Platelets \u2265100 \u00d7 109/L\n 3. Haemoglobin \u226590 g/L (9 g/dL)\n - Coagulation profile within the normal range\n - Meeting reproductive status requirements:\n 1. Must not be pregnant or breastfeeding\n 2. Female patients of childbearing potential, must have a negative serum or urine\n pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human\n chorionic gonadotrophin) within 24 hours before the first dose of study treatment\n 3. Female patients of childbearing potential who are heterosexually active must\n agree to use a highly effective method of contraception to prevent pregnancy, for\n the duration of study treatment and 6 months following the last dose of study\n treatment. Female patients who are continuously not heterosexually active are\n exempt from contraceptive requirements, but must still undergo pregnancy testing\n 4. Female patients who are heterosexually active, irrespective of childbearing\n status, must ensure their male partner agrees to use a condom with spermicide\n during sexual intercourse for the duration of study treatment and 6 months\n following the last dose of study treatment\n 5. Patients must be willing to refrain from egg donation during treatment and for at\n least 6 months following the last dose of study treatment\n 6. Male patients who are sexually active with men or women must agree to use a\n condom with spermicide during intercourse for the duration of study treatment and\n 6 months following the last dose of study treatment. In addition, patients must\n be willing to refrain from sperm donation during this time.\n - Exclusion Criteria:\n - Prior or planned allogeneic or autologous bone marrow or organ transplantation\n - Splenectomy\n - Active infections requiring antibiotics, physician monitoring or systemic therapy\n within 1 week of the anticipated first dose of study drug, or recurrent fevers\n (>38.0\u02daC) associated with a clinical diagnosis of active infection\n - Treatment with the antiviral agents: ribavirin, adefovir, lamivudine or cidofovir\n within 10 days prior to the first dose of study treatment; or pegylated interferon in\n the 4 weeks before the first dose of study treatment\n - Active viral disease or positive test for hepatitis B virus using hepatitis B surface\n antigen test or positive test for HCV using HCV ribonucleic acid (RNA) or HCV antibody\n test indicating acute or chronic infection. Positive test for HIV or AIDS\n - Patients who have active, known or suspected autoimmune disease that has required\n systemic therapy in the past 2 years, are immunocompromised in the opinion of the\n Investigator, or are receiving systemic immunosuppressive treatment\n a. Patients with vitiligo, type I diabetes mellitus, asthma/atopy, residual\n hypothyroidism due to autoimmune disease (which only requires hormone replacement\n therapy), or conditions not expected to recur in the absence of an external trigger\n are permitted to enrol providing they comply with the other eligibility criteria\n relating to renal function. Use of inhaled corticosteroids, local steroid injection,\n or steroid eye drops is allowed\n - Treatment with any live, live-attenuated or COVID-19 vaccine in the 30 days before the\n first dose of NG-641 or nivolumab (COVID-19 vaccines known not to be\n live/live-attenuated or based on an adenoviral vector (e.g. mRNA vaccines) are not\n subject to the 30-day exclusion)\n - Treatment with any other vaccine (including known non-live/live-attenuated and\n non-adenoviral COVID-19 vaccines) in the 7 days before the first dose of NG-641\n - History of prior Grade 3-4 acute kidney injury or other clinically significant renal\n impairment\n - History of clinically significant interstitial lung disease or non-infectious\n pneumonitis\n - Lymphangitic carcinomatosis (clinically suspected or radiographic evidence)\n - Infectious or inflammatory bowel disease in the 3 months before the first dose of\n study treatment\n - Myocardial infarction, stroke or other significant cardiovascular or cerebrovascular\n event in the 12 months before the first dose of study treatment\n - Pulmonary embolism, deep vein thrombosis, or other uncontrolled thromboembolic event\n in the 12 months before the first dose of study treatment, or current treatment with\n therapeutic or prophylactic anticoagulation therapy\n - Grade 3 or 4 gastrointestinal bleeding (or risk factors for gastrointestinal bleeding)\n or haemoptysis in the 3 months before first dose of study treatment, or any history of\n bleeding requiring an investigative procedure (e.g. endoscopy), transfusion or\n hospitalisation in the 12 months before the first dose of study treatment\n - Tumour location/extent considered by the Investigator to present a significant risk if\n tumour flare or necrosis were to occur (e.g. an initial increase in tumour size that\n may lead to intestinal, airway or ureter obstruction, or penetrating tumour\n infiltration of major blood vessels, or other hollow organs potentially at risk of\n perforation)\n - Use of the following prior therapies/treatments:\n 1. Treatment with any other enadenotucirev-based virus (parent virus or\n transgene-modified variants), or fibroblast activation protein (FAP) targeting\n agent at any time\n 2. Treatment with an investigational or licensed anti-cancer monoclonal antibody\n (mAb), immune checkpoint inhibitor, immune stimulatory treatment or other\n biological therapy in the 28 days prior to the first dose of study treatment.\n - Prior anti-PD-1/PD-L1 therapy is permitted without a 'washout' phase c. Treatment with\n an investigational or licensed chemotherapy, targeted small molecule or other\n investigational drug in the 14 days or five half-lives (whichever is shorter) before\n the first dose of study treatment d. Major surgery in the 28 days before the first\n dose of study treatment e. Radiation therapy in the 14 days before the first dose of\n study treatment f. Treatment with complementary medications (e.g. herbal supplements\n or traditional Chinese medicines) to treat the disease under study within the 14 days\n prior to first study treatment. Such medications are permitted if they are used as\n supportive care g. Bisphosphonate therapy or treatment with Receptor Activator of\n Nuclear factor Kappa-\u0392 (RANK)-ligand inhibitors for metastatic bone disease is\n permitted\n - All toxicities attributed to prior anti-cancer therapy (including radiation therapy)\n other than alopecia must have resolved to Grade 1 or baseline before the first dose of\n study treatment\n - Known allergy or hypersensitivity (Grade \u22653) to NG-641 transgene, immune checkpoint\n inhibitor products or formulation, or other monoclonal antibodies\n - Discontinuation from prior treatment with an immune therapy due to a Grade \u22653\n immune-related AE, or any history of life-threatening toxicity related to prior immune\n therapy\n - Other prior malignancy active within the previous 3 years, except for local or organ\n confined early stage cancer that has been definitively treated with curative intent,\n does not require ongoing treatment, has no evidence of residual disease and has a\n negligible risk of recurrence and is therefore unlikely to interfere with the primary\n and secondary endpoints of the study, including response rate and safety\n - Symptomatic brain metastases or any leptomeningeal metastases that are symptomatic\n and/or requires treatment\n - Any serious or uncontrolled medical disorder that, in the opinion of the Investigator\n or the Medical Monitor, may increase the risk associated with study participation or\n study treatment administration, impair the ability of the patient to receive protocol\n therapy or interfere with the interpretation of study results", "output": {"inclusion_biomarker": [["MSI-high"], ["dMMR"]], "exclusion_biomarker": []}}
 {"input": "This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to\n evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-21668 in\n solid tumor patients. In dose escalation phase, biomarker status is not required, but in dose\n expansion phase patients are required to harbor PIK3CA mutation.\n ;NA;\n Inclusion Criteria:\n 1. Age \u226518 and \u226470 years, male and female patients;\n 2. Life expectancy \u2265 12 weeks;\n 3. ECOG performance score 0-1;\n 4. Locally advanced or relapsed/metastatic solid tumor patients, who had disease\n progression after standard therapy, intolerable to standard therapy or for whom no\n standard therapy exists, PIK3CA mutation status is required for dose expansion phase;\n 5. Evaluable lesion required for dose escalation phase and measurable lesion as per\n RECIST 1.1 required for dose expansion phase;\n 6. Adequate organ function;\n 7. Signed informed consent.\n Exclusion Criteria:\n 1. Prior use of PI3K\u3001mTOR or AKT inhibitor;\n 2. Prior other malignant tumor;\n 3. Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases ;\n 4. Type I or type II diabetes;\n 5. Inadequate wash-out of prior anti-cancer therapies;\n 6. Cardiac disorders;\n 7. Instable systemic diseases;\n 8. Acute or chronic pancreatitis;\n 9. Pregnancy or lactation;\n 10. Other protocol specified criteria.", "output": {"inclusion_biomarker": [["PIK3CA mutation"]], "exclusion_biomarker": []}}
-{"input": "An open-label, two-part Phase I/Ib study of RP12146 in adult patients with locally advanced\n or metastatic solid tumors. The first part (Part 1) is a Phase I dose-escalation, 3+3 design,\n open-label, MTD determination study and will enroll patients who have tumors known to harbour\n DNA repair deficiencies. The second part (Part 2) is a Phase Ib, dose-expansion at the MTD\n (or optimal dose) and will enroll patients with a confirmed deleterious HRR mutation in their\n tumor as identified by a central genomics testing laboratory.\n ;NA;\n Inclusion Criteria.\n 1. Provision of full informed consent prior to any study-specific procedures.\n 2. Patients must be \u226518 years of age, at the time of signing informed consent.\n 3. Dose escalation phase, patients with histologically and/or cytologically confirmed\n malignant solid tumor whose disease has progressed following at least one standard\n therapy and who have no other acceptable standard treatment options. Tumor types will\n include breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small\n cell lung cancer (ES-SCLC), prostate, pancreatic, colorectal gastric, biliary tract,\n and endometrial cancer.\n 4. Dose-expansion phase patients with histologically and/or cytologically confirmed\n malignant solid tumor (breast, ovarian, fallopian tube, or peritoneal cancer,\n extensive-stage small cell lung cancer (ES-SCLC), with one of the documented\n deleterious mutations of specified HRR genes and whose disease has progressed\n following at least one standard therapy.\n 5. Patients with at least one measurable lesion per RECIST version 1.1 at baseline that\n can be accurately assessed by CT-scan or MRI and is suitable for repeated assessment\n at follow up-visits.\n 6. ECOG performance status 0 to 2.\n 7. Use of contraception measures\n Exclusion Criteria:\n 1. Patients with HER2 positive breast cancer\n 2. Patients receiving anticancer therapy\n 3. Patient who has not recovered from acute toxicities of previous therapy except\n treatment-related alopecia.\n 4. Prior treatment with a PARP inhibitor\n 5. Major surgery within 4 weeks of starting study treatment or any patient who has not\n recovered from the effects of major surgery.\n 6. Patient with symptomatic uncontrolled brain metastasis.\n 7. Pregnancy and lactation\n 8. Patients with uncontrolled disease", "output": {"inclusion_biomarker": [["HRR mutation"]], "exclusion_biomarker": [["HER2 positive "]]}}
+{"input": "An open-label, two-part Phase I/Ib study of RP12146 in adult patients with locally advanced\n or metastatic solid tumors. The first part (Part 1) is a Phase I dose-escalation, 3+3 design,\n open-label, MTD determination study and will enroll patients who have tumors known to harbour\n DNA repair deficiencies. The second part (Part 2) is a Phase Ib, dose-expansion at the MTD\n (or optimal dose) and will enroll patients with a confirmed deleterious HRR mutation in their\n tumor as identified by a central genomics testing laboratory.\n ;NA;\n Inclusion Criteria.\n 1. Provision of full informed consent prior to any study-specific procedures.\n 2. Patients must be \u226518 years of age, at the time of signing informed consent.\n 3. Dose escalation phase, patients with histologically and/or cytologically confirmed\n malignant solid tumor whose disease has progressed following at least one standard\n therapy and who have no other acceptable standard treatment options. Tumor types will\n include breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small\n cell lung cancer (ES-SCLC), prostate, pancreatic, colorectal gastric, biliary tract,\n and endometrial cancer.\n 4. Dose-expansion phase patients with histologically and/or cytologically confirmed\n malignant solid tumor (breast, ovarian, fallopian tube, or peritoneal cancer,\n extensive-stage small cell lung cancer (ES-SCLC), with one of the documented\n deleterious mutations of specified HRR genes and whose disease has progressed\n following at least one standard therapy.\n 5. Patients with at least one measurable lesion per RECIST version 1.1 at baseline that\n can be accurately assessed by CT-scan or MRI and is suitable for repeated assessment\n at follow up-visits.\n 6. ECOG performance status 0 to 2.\n 7. Use of contraception measures\n Exclusion Criteria:\n 1. Patients with HER2 positive breast cancer\n 2. Patients receiving anticancer therapy\n 3. Patient who has not recovered from acute toxicities of previous therapy except\n treatment-related alopecia.\n 4. Prior treatment with a PARP inhibitor\n 5. Major surgery within 4 weeks of starting study treatment or any patient who has not\n recovered from the effects of major surgery.\n 6. Patient with symptomatic uncontrolled brain metastasis.\n 7. Pregnancy and lactation\n 8. Patients with uncontrolled disease", "output": {"inclusion_biomarker": [["HRR deleterious mutation"]], "exclusion_biomarker": [["HER2 positive"]]}}
 {"input": "This is a prospective, open-label, single-center clinical trial. This study will evaluate the\n safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7\n positive T-ALL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the\n incidence of treatment emergent adverse event (TEAE).\n ;NA;\n Inclusion Criteria:\n 1. Total bilirubin \u2264 51 \u03bcmol / L, ALT and AST \u2264 3 times of the upper limit of normal\n value, serum creatinine \u2264 176.8 \u03bcmol / L;\n 2. Echocardiography shows left ventricular ejection fraction (LVEF) \u2265 50%;\n 3. There is no active pulmonary infection, and the oxygen saturation during air\n inhalation is more than 92%;\n 4. The estimated survival time is more than 3 months;\n 5. ECOG score was 0-2;\n 6. The patients or their legal guardians voluntarily participated in the trial and signed\n the informed consent.\n For T-ALL:\n 1. Patients is histologically diagnosed with CD7 Positive T-ALL according to the Clinical\n Practice Guidelines for Acute Lymphoblastic Leukemia (ALL) (2020. V1) by National\n Comprehensive Cancer Network (NCCN).\n 2. The diagnosis is consistent with r/r CD7 + T-ALL, and includes any of the following\n conditions:\n 1. No CR was obtained by standard chemotherapy;\n 2. The first induction was CR, but the duration of CR was less than 12 months;\n 3. No CR was obtained after the first or multiple remedial treatment;\n 4. Relapse twice or more;\n 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1%\n (flow cytometry).\n For T-NHL:\n 1. Patients is histologically diagnosed with CD7 Positive T-NHL according to The 2016\n revision of the World Health Organization classification of lymphoid neoplasms.\n 2. r/r T-NHL, and includes any of the following conditions:\n 1. No response or relapse after second or more lines of chemotherapy;\n 2. Primary refractory ot chemotherapy;\n 3. Relapse after autologous stem cell transplantation;\n 3. According to the Lugano 2014 criteria, there is at least one evaluable tumor lesion.\n For AML:\n 1. Patients is histologically diagnosed with CD7 Positive AML according to the Clinical\n Practice Guidelines for Acute Myeloid Leukemia (AML) (2020. V3) by National\n Comprehensive Cancer Network (NCCN).\n 2. The diagnosis is consistent with r/r CD7 + AML, and includes any of the following\n conditions:\n 1. No CR was obtained by standard chemotherapy;\n 2. The first induction was CR, but the duration of CR was less than 12 months;\n 3. No CR was obtained after the first or multiple remedial treatment;\n 4. Relapse twice or more;\n 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1%\n (flow cytometry).\n Exclusion Criteria:\n 1. Patients with history of epilepsy or other central nervous system diseases;\n 2. Patients with prolonged QT or severe heart disease;\n 3. Pregnant or lactating women (the safety of this therapy for unborn children is\n unknown);\n 4. The patients with uncontrolled active infection;\n 5. Active hepatitis B or hepatitis C virus infection;\n 6. Previous application of gene therapy;\n 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;\n 8. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;\n 9. Those who suffer from other uncontrolled diseases are not suitable to join the study;\n 10. HIV infection;\n 11. Any situation that the researchers believe may increase the risk of patients or\n interfere with the test results.", "output": {"inclusion_biomarker": [["CD7 positive"]], "exclusion_biomarker": []}}