[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Kechow Pharma, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":118},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,71,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100516714","phase-3-efficacy-and-safety-of-tunlametinib-plus-vemurafenib-in-patients-with-braf-v600e-mutant-metastatic-colorectal-cancer-100516714",false,"NCT06008119","Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer","A Multicenter, Randomized, Open-label, Phase 3 Study to Evaluate the Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Inclusion Criteria:\n\n  1. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.\n  2. Male or female patients with 18 to 70 years of age at time of informed consent;\n  3. Histological or cytologically confirmed metastatic CRC\n  4. Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory (BRAFV600 is permitted)\n  5. Able to provide a sufficient amount of representative tumor specimen (primary or metastatic, archival or newly obtained) for confirmatory central laboratory testing of BRAF mutation status.\n  6. Progression of disease after 1 or more prior regimens in the metastatic setting\n  7. At least 1 site of radiographically measurable disease by RECIST 1.1\n  8. Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 1;\n  9. Life expectancy ≥ 3 months;\n  10. Can swallow the medicine,\n  11. Adequate hematologic, renal, cardiac and liver function as defined by laboratory values performed within 7 days prior to initiation of dosing:\n  12. Be willing and able to complete all the study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n* Exclusion Criteria:\n\n  1. Prior treatment with any BRAF and MEK inhibitor;\n  2. Known contraindication to receive the treatment of control arm (according to latest PI).\n  3. Symptomatic brain metastasis or leptomeningeal disease\n  4. History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization\n  5. Known history of acute or chronic pancreatitis\n  6. Uncontrolled GI bleeding, Dysphagia，refractory nausea, vomiting, small bowel resection or any other gastrointestinal ailment that would preclude study drug absorption.\n  7. Serious cardiovascular disease , including uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia , deep vein thrombosis or pulmonary emboli or cerebrovascular events ≤ 6 months prior to starting study treatment;\n  8. History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)\n  9. Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)\n  10. Uncontrolled blood pressure despite medical treatment\n  11. Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy\n  12. Residual common terminology criteria for adverse events (CTCAE) ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy\n  13. Anti-HIV(+) , Anti-TP( +); Active hepatitis B or hepatitis C infection …….","ALL","18 Years","70 Years",{"count":20,"type":21},165,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, randomized, open-label, Phase 3 study",[27],"Colorectal Cancer Metastatic",[29],"BRAFV600E mutant","RECRUITING","2025-09-12",{"date":33,"type":34},"2025-09-18","ACTUAL",{"date":36,"type":34},"2023-10-25",{"date":38,"type":21},"2026-12-24",{"name":40,"class":41},"Shanghai Kechow Pharma, Inc.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"100582752","phase-1-safety-tolerability-and-pharmacokinetics-of-hl-003-in-healthy-subjects-100582752","NCT06867393","Safety, Tolerability, and Pharmacokinetics of HL-003 in Healthy Subjects","Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-003 in Healthy Subjects","Inclusion Criteria:\n\n1. Volunteers must be between 18 and 50 years old (inclusive), healthy, and can be of any gender.\n2. Males must weigh ≥50 kg, and females must weigh ≥45 kg. The Body Mass Index (BMI) should be within the range of 19 to 26 kg\u002Fm² (including the threshold values).\n3. Serum creatinine levels must be within the normal range during the screening period, and the Creatinine Clearance (CCr) must be ≥90 mL\u002Fmin (including the threshold value, calculated using the CKD-EPI formula.\n4. Comprehensive physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray (posteroanterior view), and laboratory tests (including blood routine, blood biochemistry, thyroid function, parathyroid function, coagulation function, urinalysis, etc.) must all be within normal ranges or show no clinically significant abnormalities.\n5. Participants must agree not to plan for pregnancy during the trial and for 3 months after taking the medication, and must use reliable contraceptive methods.\n6. Participants must be able to communicate effectively with researchers, fully understand the purpose, methods, requirements, and potential adverse reactions of the trial, voluntarily participate in the clinical trial, sign a written informed consent form, and be able to complete the clinical trial according to the protocol requirements.\n\nExclusion Criteria:\n\n1. History of known allergy to the investigational drug or any of its components\u002Frelated formulations; history of allergic reactions to two or more medications, foods, etc., or individuals with hypersensitive constitution;\n2. Subjects with special dietary requirements who cannot comply with standardized meals;\n3. History of frequent nausea or vomiting from any cause;\n4. QTcF interval \\>450 msec (calculation formula in Appendix 14-3);\n5. Positive for HBsAg, hepatitis B e-antigen, HCV antibody, syphilis antibody, or HIV antibody;\n6. Consumption of caffeine-rich foods\u002Fbeverages within 48h before dosing, or unwillingness to abstain during the study;\n7. Any medical history\u002Fcomorbidities that may affect safety assessment or drug metabolism, including CNS, cardiovascular, digestive, respiratory, urinary, hematologic, immunological, psychiatric disorders, metabolic abnormalities, or gastrointestinal surgery (except appendectomy);\n8. Blood loss ≥400 mL or blood transfusion within 3 months before dosing; Blood donation (including component donation) ≥200 mL within 1 month before dosing;\n9. Use of CYP3A4\u002FCYP2C9\u002FCYP2C8 inhibitors\u002Finducers within 30 days before dosing; Any prescription\u002FOTC medications\u002Fherbal products within 14 days before dosing;\n10. Participation in other drug trials within 3 months before dosing;\n11. Current\u002Fpast drug addiction or positive drug abuse screening;\n12. Excessive alcohol consumption (\\>14 units\u002Fweek; 1 unit=360mL beer\u002F45mL 40% liquor\u002F150mL wine) within 3 months or unwillingness to abstain during the study;\n13. Heavy smoking (\\>5 cigarettes\u002Fday within 3 months) or inability to abstain during the study;\n14. Consumption of CYP-affecting foods (grapefruit\u002Fpomelo\u002Flime products) within 48h before dosing, or refusal to abstain during the study;\n15. Poor compliance or other investigator-determined unsuitable factors;\n16. Additional female exclusions:\n\n    1. Oral contraceptive use within 30 days before screening or during study\n    2. Long-acting estrogen\u002Fprogestin use within 6 months before screening\n    3. Unprotected intercourse within 14 days before study or during trial\n    4. Pregnancy or lactation;\n17. Directly involved research staff or their family members, or subordinate researchers.",true,"50 Years",{"count":53,"type":21},52,[55],"PHASE1","This clinical study aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of HL-003 tablets in healthy subjects. It is conducted in two sequential clinical phases: single-dose and multiple-dose escalation.",[58],"Healthy Subjects",[60,61,62],"safety, tolerability","pharmacokinetic characteristics","HL-003 tablets","2025-03-04",{"date":65,"type":34},"2025-03-10",{"date":67,"type":34},"2025-02-28",{"date":69,"type":21},"2025-09",{"name":40,"class":41},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":42},"100516713","phase-3-comparing-tunlametinib-capsules-and-combination-chemotherapy-in-advanced-nras-mutant-melanoma-100516713","NCT06008106","Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma","Efficacy and Safety of Tunlametinib Capsules Versus Combination Chemotherapy of Investigator's Choice in Advanced NRAS-mutant Melanoma Patients Who Had Previously Received Immunotherapy","Inclusion Criteria:\n\n1. ≥ 18 years of age.\n2. Patients with unresectable stage III or metastatic IV melanoma confirmed by histology or cytology.\n3. History of immunotherapy failure or could not tolerate immunotherapy\n4. NRAS mutation at baseline;.\n5. There is at least one lesion that can be evaluated as target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n6. Eastern cooperative oncology group (ECOG) performance status of grade 0-1.\n7. Life expectancy \\> 3 months.\n8. No major surgery (excluding baseline tumor biopsy) or major trauma occurred at least 4weeks prior to investigational drug administration.\n9. Left ventricular ejection fraction (LVEF) ≥ 50% within 7 days before dosing according to echocardiographic findings.\n10. Key laboratory tests must be conducted within 7 days before dosing and meet the inclusion criteria:\n11. Able to understand and voluntarily sign the Informed Consent Form.\n12. Patients must be willing and able to complete the study procedure and follow-up examination.\n\nExclusion Criteria:\n\n* Exclusion Criteria:\n\n  1. Having the following treatment before receiving the study drug: ① received chemotherapy, targeted therapy or other study drug treatment within 4 weeks before the first administration or within 5 half lives of the drug (whichever is longer); ② received immunotherapy and biological therapy within 4 weeks before the first administration; ③ received traditional Chinese medicines with anti-tumor activities approved by National Medical Products Administration (NMPA) within 2 weeks before the first administration.;\n  2. The toxic reactions of previous anti-tumor treatment have not been recovered;\n  3. Current use of other anti-cancer drugs.\n  4. Subjects with symptomatic or untreated brain metastasis, meningeal metastasis or spinal cord compression except for subjects with asymptomatic brain metastasis;\n  5. History of any of the following within 6 months of screening: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass grafting, symptomatic congestive heart failure, severe heart arrhythmia requiring medication, uncontrolled hypertension, cerebrovascular accident, or transient ischemic attack, diabetic ketoacidosis, deep vein thrombosis, or symptomatic pulmonary embolism.\n  6. ECG Corrected Q-T interval formula (QTcB) ≥ 480 msec (adjusted by Bazett's formula) during screening, or a history of congenital long QT syndrome.\n  7. History or current evidence of retinal diseases;\n  8. Previous or current neuromuscular diseases related to CK elevation;\n  9. Previous or current interstitial lung disease or interstitial pneumonitis;\n  10. Uncontrolled concomitant diseases or infectious diseases.\n  11. Bleeding symptoms of grade 3 as defined by the National Cancer Institute General Terminology Standard for Adverse Events (NCI CTCAE V5.0) within the 4 weeks prior to study initiation.\n  12. Inability to swallow the capsule, refractory nausea and vomiting, malabsorption, external biliary diversion, or any small intestinal resection that would preclude adequate absorption of the study drug.\n  13. Patients who are receiving and cannot discontinue regimen-prohibited intravenous or oral drugs that affect CYP isoenzymes (strong inducers and strong inhibitors of CYP2C9) at least 1 week prior to initiation of study treatment and during the study period.\n  14. Patients with a history of malignancy within the past 5 years;\n  15. Human immunodeficiency virus (HIV) antibody positive; syphilis antibody (anti-TP) positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; HBsAg positive and HBV DNA positive.\n  16. Patients who have been previously treated with MEK inhibitors.\n  17. Patients with known hypersensitivity to investigational drug, proposed chemotherapy or their analogues.\n  18. History of allogeneic bone marrow transplantation or organ transplantation.\n  19. Serum pregnancy test results are positive for premenopausal female patients;\n  20. Other severe, acute, or chronic clinical or psychiatric disorders or laboratory abnormalities that may increase the risk and interfere with the study results in the opinion of investigator.",{"count":20,"type":21},[24],"This is a multicenter, two-arm, open-label, randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigator's choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before. Subjects were stratified according to the baseline lactate dehydrogenase level and chemotherapy.",[82],"Melanoma",[84,85,82],"Mitogen-Activated Protein Kinase Kinases","NRAS","2024-06-26",{"date":88,"type":34},"2024-06-28",{"date":90,"type":34},"2023-11-02",{"date":92,"type":21},"2027-09-22",{"name":40,"class":41},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":42},"100464700","phase-2-hl-085-in-adults-with-neurofibromatosis-type-1-nf1-and-inoperable-plexiform-neurofibromas-100464700","NCT05331105","HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas","A Multi-center, Open-label, Single-arm Phase II Study to Evaluate the Efficacy and Safety of HL-085 in the Treatment of Adult Participants With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas","Inclusion Criteria:\n\n* Age: patients must be ≥18 years of age at the time of study entry.\n* Diagnosis: Patients must have inoperable and symptomatic plexiform neurofibromas(PN), and patients must have NF1 mutation or meet at least 1 of the following NF1 diagnostic criteria:\n\n  ① ≥6 cafe-au-lait macules ;\n\n  ② Axillary freckling or freckling in inguinal regions;\n\n  ③ ≥2 Lisch nodules (iris hamartomas);\n\n  ④ A distinctive bony lesion such as dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex);\n\n  ⑤ An optic pathway glioma;\n\n  ⑥ First-degree relative with NF1.\n* Patients must have a measurable lesion, defined as at least 3 cm in length, amenable to MRI for efficacy assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patients are able to understand and voluntarily sign a written informed consent form.\n* Patients must be willing and able to complete study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n* Patients who are unable to undergo MRI scans (prosthesis, prosthesis, braces, etc.) or patients with lesions that cannot be evaluated by MRI.\n* Patients do not have adequate organ function.\n* Patients who are unable to take drugs orally, have difficulty swallowing or anything that may lead to inadequate drug absorption.\n* Prior treatment with MEK 1\u002F2 inhibitors.\n* Patients known to be allergic to the ingredients or analogues of the study drug.\n* Patients with previous or current retinal diseases such as retinal vein occlusion (RVO), retinal pigment epithelium detachment (RPED), central serous retinopathy (CSR), etc. (except retinopathy caused by research diseases).\n* With infections or other uncontrolled disease.\n* Strong CYP2C9 inhibitors or inducers within 7 days before treatment of the study drug.\n* Patients who received surgery within 4 weeks or radiotherapy within 6 weeks before enrollment.\n* Patients who participated in any other clinical study treatment within 4 weeks before enrollment.\n* Patients treated with anti-NF1 treatment with unresolved chronic toxicity.\n* Clinical judgment by the investigator that the patient should not participate in the study.","80 Years",{"count":103,"type":21},70,[105],"PHASE2","This is a Multi-center, Open-label, Single-arm Phase II Study to Evaluate the Efficacy and Safety of HL-085 in the treatment of Adult Participants with Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas(PN)",[108,109],"Neurofibromatosis 1","Plexiform Neurofibromas","2023-05-29",{"date":112,"type":34},"2023-05-31",{"date":114,"type":34},"2021-10-18",{"date":116,"type":21},"2028-10-31",{"name":40,"class":41},""]