[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Haihe Biopharma Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,68,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100591068","phase-1-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-cyh33-in-patients-with-pik3ca-related-overgrowth-spectrum-pros-and-pik3ca-related-vascular-malformations-prvm-100591068",false,"NCT06975618","Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Patients With PIK3CA-related Overgrowth Spectrum (PROS) and PIK3CA-related Vascular Malformations (PRVM)","A Phase I\u002FII, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CYH33 (a Selective PI3Kα Inhibitor) in Patients With PIK3CA-related Overgrowth Spectrum (PROS) and PIK3CA-related Vascular Malformations (PRVM)","Key inclusion criteria:\n\n1. The patient or the patient's legal guardian (if applicable) voluntarily signs the Informed Consent Form.\n2. At the time of signing the informed consent, adult patients should be ≥18 years old (or meet the legal adult age according to local regulations), and adolescent patients should be ≥12 years old and \\\u003C18 years old (or meet the legal definition of adolescent according to local regulations; additionally, adolescent patients should weigh ≥35 kg).\n3. The patient is diagnosed with PIK3CA-related overgrowth spectrum (PROS) or PIK3CA-related vascular malformations (PRVM), and provides a report confirming PIK3CA mutation detected by local laboratory or the Sponsor-designated central laboratory, with at least one measurable lesion related to PROS or PRVM.\n4. Patients should demonstrate adequate organ and bone marrow function during the 28-day screening period.\n\nKey exclusion criteria:\n\n1. PROS patients presenting solely with isolated macrodactyly, epidermal nevi\u002Fnevus, and megalencephaly (only one clinical feature or any combination of these three features) without other PROS-related lesions.\n2. Patients who have received any systemic treatment for PROS or PRVM within 8 weeks prior to the first dose of study drug, or any drug treatment for PROS or PRVM (e.g., mTOR inhibitors) within 28 days prior to the first dose of study drug.\n3. Patients who have previously received any PI3K inhibitor treatment.","ALL",{"count":18,"type":19},141,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","This study is a multi-center, open-label, single arm, phase I\u002FII study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 in patients with PIK3CA-related overgrowth spectrum (PROS) and PIK3CA-related vascular malformations (PRVM)",[26,27],"PIK3CA-Related Overgrowth Spectrum (PROS)","PIK3CA-related Vascular Malformations (PRVM)","RECRUITING","2026-06-26",{"date":31,"type":32},"2026-06-29","ACTUAL",{"date":34,"type":32},"2023-08-22",{"date":36,"type":19},"2029-12-31",{"name":38,"class":39},"Haihe Biopharma Co., Ltd.","INDUSTRY",15,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100586015","phase-1-study-to-evaluate-efficacy-and-safety-of-hh2853-in-relapsedrefractory-peripheral-t-cell-lymphoma-100586015","NCT06909877","Study to Evaluate Efficacy and Safety of HH2853 in Relapsed\u002FRefractory Peripheral T-cell Lymphoma","An Open-label, Multinational, Multicenter, Single-arm Phase Ⅰb\u002FⅡ Study to Evaluate Efficacy and Safety of Oral HH2853, a Selective EZH1\u002F2 Inhibitor, in Patients With Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* main inclusion:\n\n  1. Tumor types and prior antitumor therapy: Phase Ib:Dose Escalation: All enrolled patients must have histologically confirmed diagnosis NHL who have received at least one line of prior systematic treatment (and ≤ 5 lines) and relapses or refractory. Phase Ib dose expansion part: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK + ALCL, ALK-ALCL, NKTCL, enteropathy associated T-cell lymphoma (EATL), monomorphic epitheliotropic internal T-cell lymphoma (MEITL), Hepatosplenic T-cell lymphoma (HSTCL), follicular T-cell lymphoma (FTCL), Nodal peripheral T-cell lymphoma with TFH phenotype (Nodal PTCL-TFH) and other invasive T-cell sources NHL at the investigator and sponsor's discretion (except highly invasive). All enrolled patients had relapsed or refractory diseases after receiving 1-line systematic treatment (≤ 3 lines). Phase II: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL, NKTCL, EATL, MEITL, HSTCL, FTCL, Nodal PTCL-TFH et al. Patients must have histologically confirmed diagnosis of R\u002FR PTCL who have received at least one line of prior systematic combination chemotherapy and at least one new drug therapy (prior antitumor treatment lines ≤4 lines) : relapse and\u002For refractory.\n  2. Availability of qualified tissue samples by patient for pathological diagnosis by the central laboratory.\n  3. The Eastern cooperative oncology group (ECOG) score 0-1.\n  4. Life expectancy ≥ 3 months before starting HH2853 treatment.\n  5. Sufficient bone marrow, liver and renal functions.\n\nExclusion Criteria:\n\n* main criteria:\n\n  1. Previous treatment with EZH2 or EZH1\u002F2 inhibitors.\n  2. Central nervous system invasion.\n  3. Any previous history of bone marrow malignancy, including myelodysplastic syndrome (MDS).\n  4. Received medications that are known potent CYP3A4 inducers\u002Finhibitors within 1 week prior to first dose.","18 Years","75 Years",{"count":51,"type":19},100,[22,23],"This study is a an open-label, multinational, multicenter, single-arm Phase Ⅰb\u002FⅡ Study to Evaluate Efficacy and Safety of Oral HH2853 in Patients with Relapsed\u002FRefractory Peripheral T-cell Lymphoma.",[55],"Relapsed\u002FRefractory Peripheral T-Cell Lymphoma (R\u002FR PTCL)",[57,58],"Relapsed\u002FRefractory","Peripheral T-cell Lymphoma","2026-01-28",{"date":61,"type":32},"2026-01-30",{"date":63,"type":32},"2022-07-27",{"date":65,"type":19},"2027-07-30",{"name":38,"class":39},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":20,"phases":77,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100392493","phase-1-evaluate-the-safety-and-clinical-activity-of-hh2853-100392493","NCT04390737","Evaluate the Safety and Clinical Activity of HH2853","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients With Relapsed\u002FRefractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors","Inclusion criteria:\n\n1. Provided signed written informed consent prior to initiation of any study-related procedures;\n2. Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age);\n3. Tumor type criteria:\n\nThe specific requirements for specific subtypes of recurrent\u002Frefractory non Hodgkin's lymphoma (NHL) confirmed by histology are as follows:\n\nHistologically confirmed follicular lymphoma (FL) that has been treated with at least two lines of systemic therapy (at least one regimen based on anti-CD20 monoclonal antibodies) according to GELF criteria or as determined by researchers (Grade 1-3a); Relapsed\u002Frefractory diffuse large B-cell lymphoma - non-specific (DLBCL NOS, 2016 World Health Organization Lymphoma Classification) that has received at least two treatment regimens in the past (at least one with CD20 monoclonal antibody as the main treatment, with a maximum number of treatment lines\\\u003C5), and is not a candidate for salvage treatment or autologous\u002Fallogeneic stem cell transplantation.\n\nRelapsed\u002Frefractory clinicopathologically documented PTCL with at least 1 line of prior systemic treatment (maximum \\\u003C5 lines). Solid tumors that meet the following criteria:\n\n1. Histologically or cytologically documented advanced recurrent or metastatic solid tumor.\n2. Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target lesions by RECIST v1.1 in at least 1 site. (Lesions that have been treated with radiotherapy or other local treatment are generally considered unmeasurable unless there is definite progression of the lesion.)\n3. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. One of the following criteria should be met.\n\nPatients must experience at least one prior standard therapy. Disease progression occurred on or after last line of therapy, or intolerant to last line of therapy (maximum ≤3 lines, Patients without treatment options available known to provide clinical benefit are also eligible upon agreement from investigator and sponsor) There is no approved therapy, or for which standard therapy is unsuitable or refused by patients after being fully informed.\n\nFor epithelioid sarcoma in Phase I and Phase II cohort 2:\n\n1. Confirmed by local histology or cytology\n2. Patients with unresectable locally delayed or metastatic epithelioid sarcoma who have undergone treatment (including those who have failed treatment and developed intolerable toxicity).\n\nFor solid tumors in Phase I and Phase II queue 3:\n\n1. Confirmed by local pathology as advanced recurrent or metastatic solid tumor.\n2. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1; 5. Availability of archival tissue within three years 6. Relapsed\u002FRefractory FL, Epithelioid sarcoma, relapsed\u002Frefractory PTCL, other relapsed\u002Frefractory non-Hodgkin's lymphomas with EZH2 mutation, and advanced solid tumors with specific genetic alterations, including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or\u002Fand SMARCA4 mutation 7. Predicted life expectancy of ≥ 3 months; 8. Patient must meet the following laboratory values: 1.Serum total Bilirubin ≤ 1.5 x ULN or ≤ 3.0 mg\u002FdL for patients with Gilbert's syndrome 2.AST\u002FSGOT and ALT\u002FSGPT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present 3.24-hour creatinine clearance (calculated\\* or measured value\\*\\*)≥ 50 mL\u002Fmin 4.Platelets ≥ 1 x LLN (no Platelet transfusion for 7 days prior to screening) 5.Hemoglobin (Hgb) ≥ 9 g\u002FdL 6.Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\\^9\u002FL 7.Adequate coagulation function: International normalized ratio (INR) \\\u003C1.3 (or \\\u003C3.0 on anticoagulants) 9. Measurable lesion\n\nExclusion Criteria:\n\n1. Any cancer-directed therapy within 28 days or five half-lives prior to first dose; Small molecule anticancer therapy within 2 weeks or five half-lives; Local radiotherapy within 14 days of first dose.\n2. Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.\n3. Patients with prior transplant are excluded;\n4. Major surgery within 4 weeks prior to first dose;\n5. A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose;\n6. HIV (human immunodeficiency virus) infection, active hepatitis B or hepatitis C patients (HBsAg positive patients with HBV (hepatitis B virus) DNA ≥ 10\\^3 copies or ≥ 200 IU\u002FmL; HCV antibody test results are positive, and HCV (hepatitis C virus) RNA PCR test results are positive).\n7. Concomitant malignancies or previous malignancies\n8. Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited except low molecular weight heparin and direct oral anticoagulants.\n9. Any toxicities from prior treatment that have not recovered to ≤ CTCAE Grade 1\n10. There were ≥ 3 lesions with punctate bleeding, any active bleeding, intratumoral bleeding, known bleeding tendencies, or treatment with antiplatelet\u002Fantithrombotic drugs.\n11. Gastrointestinal condition which could impair absorption of study medication;\n12. Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol;\n13. Cardiac exclusion criteria:\n\n1.History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 3 months prior to first dose of study drug; 2.Fridericia's corrected QT interval (QTcF) \\> 450 ms (for male) and \\> 470 ms (for female) on ECG conducted during screening; 3.Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death; 4.History or current evidence of serious uncontrolled ventricular arrhythmias; 5.Symptomatic congestive heart failure (Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system) within the previous 3 months; 6.Left ventricular ejection fraction (LVEF) \\\u003C 50%; 14. Any evidence of serious active infections requiring antibiotics; 15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or their excipients; 16. Pregnant or breast-feeding female; 17. Contraception: 18. Other serious illness or medical conditions at the Investigator's discretion, that may influence study results 19. Previously received treatment with EZH2 or EZH1\u002F2 inhibitors. 20. Grade 3b FL or evidence of transformation to invasive lymphoma",{"count":76,"type":19},254,[22,23],"This is an open-label, multicenter, first-in-human phase I\u002FII study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.",[80,81,82,83],"FL Lymphoma","Epithelioid Sarcoma","Peripheral T Cell Lymphoma","Advanced Solid Tumor",[85,86,87,88],"Phase I\u002FII","HH2853","PRC2","EZH 1\u002F2 inhibitor",{"date":61,"type":32},{"date":91,"type":32},"2020-09-08",{"date":93,"type":19},"2028-12-31",{"name":38,"class":39},25,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":20,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100383279","phase-1-assessment-of-anti-tumor-and-safety-in-glumetinib-in-patients-with-c-met-positive-non-small-cell-lung-cancer-100383279","NCT04270591","Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer","A Phase Ib\u002FII, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Glumetinib (SCC244), a Selective MET Inhibitor in Patients With Advanced Non-Small Cell Lung Cancer Harboring MET-alterations","Inclusion criteria:\n\n1. Provide informed consent voluntarily.\n2. Male and female patients ≥ 18 years of age (or having reached the age of majority according to local laws and regulations, if the age is \\> 18 years).\n3. Histologically or cytologically confirmed diagnosis of NSCLC including PSC.\n4. Patients with stage IIIb or IIIc NSCLC who are not candidates for definitive surgical resection or concurrent chemoradiation or patients with stage IV NSCLC (AJCC version 8).\n5. For Phase Ib study, patients should carry at least one of the following MET alterations (by local or Sponsor-designated central laboratory screening):\n\n   * METex14 skipping mutation who had previously treated by other MET inhibitor(s) or\n   * METex14 skipping mutation who had received 3 or more lines prior systemic therapies without MET inhibitor for the advanced NSCLC or\n   * MET amplification GCN ≥ 4 or MET\u002FCEP7 ratio ≥ 2) or\n   * MET over-expression (IHC2+).\n6. For Phase II study, patients with METex14 skipping mutation in tumor or ctDNA samples (local testing is acceptable for eligibility, however if the results of the central laboratory is available, the report of the central laboratory shall prevail); all patients in Phase II study will have confirmation of METex14 skipping mutation by Sponsor-designated central laboratory but this result is not necessary for eligibility.\n7. Availability of tumor tissue sample (either fresh tumor biopsy or archival tumor tissue sample); for patients of phase II study (not mandatory for safety run-in), if screened and enrolled based on local test results of METex14 skipping, the tumor tissue sample must be available for central laboratory testing before C2D1; if local testing results meet the requirements, patients of phase Ib are exempt from the central laboratory confirm.\n8. For Phase II study, patients are not eligible for chemotherapy or refuse chemotherapy after well-informed or have failed one or two prior lines of systemic therapies for the advanced NSCLC.\n\n   * Treatment failure is defined as documented disease progression or intolerance to treatment.\n   * Maintenance therapy given after first line chemotherapy will be considered as part of the first line if given to patients with documented response or stable disease before starting the maintenance therapy.\n   * Prior neoadjuvant\u002Fadjuvant systematic therapies will count as one prior line of treatment, provided that disease recurred within 12 months of completion of neoadjuvant\u002Fadjuvant therapy.\n9. For Phase II study, at least one measurable lesion as per RECIST 1.1. (A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation.)\n10. ECOG Performance Status (PS): 0-1.\n11. Adequate bone marrow reserve, renal and liver function:\n\n    * Absolute neutrophil count ≥ 1.5 × 109\u002FL;\n    * Hemoglobin ≥ 9 g\u002FdL;\n    * Platelet count ≥ 75 × 109\u002FL;\n    * Serum total bilirubin ≤ ULN (≤ 3 × ULN for patients with Gilbert's syndrome);\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5.0 × ULN for patients with hepatic metastasis);\n    * Creatinine clearance (calculated\\* or measured value\\*\\*) ≥ 50 mL\u002Fmin\n\n      * For calculated creatinine clearance (Ccr) value, the eligibility should be determined using the Cockcroft-Gault formula:\n\n        * Male Ccr (mL\u002Fmim) = body weight (kg) x (140-age)\u002F\\[72 x creatinine (mg\u002FdL)\\]\n        * Female Ccr (mL\u002Fmin) = male Ccr x 0.85 \\*\\* A measured value\n    * International normalized ratio (INR) \\\u003C 1.3 (or \\\u003C 3.0 if on anticoagulation)\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria shall be excluded from the study:\n\n1. Patients with targetable activating EGFR mutation, ALK rearrangement, ROS1 rearrangement, BRAF mutation or NTRK fusion that have available standard of care therapies.\n2. Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. Patients' neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new problem is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for ≥ 3 months at least two weeks prior to entering the study with treatment dose no more than dexamethasone 4 mg daily or an equivalent dose of steroids.)\n3. Prior exposure to MET-directed therapy (except patients harboring METex14 skipping in Phase Ib study).\n4. Evidence of past or current primary malignancies other than NSCLC (except for non-melanoma skin cancer, in situ breast cancer or in situ cervical carcinoma and superficial bladder cancer, or other cancer curatively treated and with no evidence of disease for at least 5 years).\n5. Subjects with clinically significant cardiovascular disease, including:\n\n   * NYHA Class III or higher congestive heart failure;\n   * History or current evidence of serious uncontrolled ventricular arrhythmias requiring drug therapy;\n   * Acute myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral artery bypass graft received within 6 months prior to the first dose;\n   * Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   * Fridericia's corrected QT interval (QTcF) \\> 460 ms on ECG conducted during screening;\n   * Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death;\n   * Clinically uncontrolled hypertension (after standard antihypertensive treatment, systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg);\n6. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2 prior neuropathy.\n7. Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C. Patients whose test results meet one of the following will not be enrolled:\n\n   * for patients in China and Japan, confirmed HIV antibody positive. For patients in the US, patients with a history of HIV but no history of AIDS or an AIDS-defining opportunistic infection are allowed to be enrolled;\n   * serum HBsAg positive and HBV DNA\\>200 IU\u002Fml or 1000 copies\u002FmL;\n\n     \\- For patients in Japan, whose results are HBsAg antigen negative; however, when HBsAb or HBcAb positive, the patients whose HBV DNA \\\u003C 200 IU\u002Fml or 1000 copies\u002FmL could be enrolled.\n   * serum HCV antibody and HCV RNA positive.\n8. Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy.\n9. Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.\n10. Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product.\n11. Patients who have to receive treatment (definite strong CYP3A4 inhibitor or inducer \\[appendix 6\\]; in addition, herbals\u002Fsupplements containing St. John's wart \\[Hypericum perforatum L.\\] and Sevillia orange etc. should also be avoided.) that is prohibited during the study and those who cannot discontinue drugs (e.g. antiarrhythmic agent) that may lead to QTc interval prolongation or torsade de pointes. Additionally, patients who have to receive treatment of strong inhibitor for CYP2C8 and\u002For CYP2C9 \\[appendix 6\\] and substrates or inhibitor for transporter \\[appendix 7\\] will be excluded in safety run-in part of the study.\n12. Any diseases or medical conditions, at the investigator's discretion, that may be unstable or influence their safety or study compliance, including organ transplantation, abuse of psychotropic medication, alcohol abuse or history of drug abuse.\n13. Other serious illness or medical conditions at the investigator's discretion, that may influence study results, including but not limited to serious infection, diabetes, cardiovascular and cerebrovascular diseases or lung disease.\n14. Patients with a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD.\n15. Pregnant or breast-feeding patients. Pregnancy refers to the state of a woman between fertilization and the end of pregnancy confirmed by positive laboratory hCG test (\\> 5 mIU\u002FmL). Breast-feeding woman can become eligible for this study if she stops breast-feeding, however, cannot restart the breast-feeding on\u002Fafter the completion of the study treatment.\n16. Man and woman with childbearing potential (WOCBP refer to appendix 3) not using effective contraception (refer to appendix 3) during the trial and within 6 months after the end of treatment","80 Years",{"count":105,"type":19},183,[22,23],"Indication:Patients with Advanced c-MET-positive Non-Small Cell Lung Cancer\n\nPhase Ib (China only):\n\nApproximately 90 patients\n\nPhase Ⅱ (globally):\n\nApproximately 78 evaluable patients; addition of at least 6 patients in Safety Run-in (US only)",[109],"C-Met Exon 14 Mutation",[111,112,113,114],"MET","MET amplification","MET over-expression","C-Met Exon 14","2022-07-28",{"date":117,"type":32},"2022-08-01",{"date":119,"type":32},"2019-07-15",{"date":121,"type":19},"2023-12-30",{"name":38,"class":39},44,""]