[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hutchmed\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":290},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,65,90,116,135,161,182,206,242,269],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643500",false,"NCT07643272","A Study on the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of HMPL-760 Capsules","An Open-Label, Randomized, Four-Period, Six-Sequence Phase I Study to Evaluate the Effect of Food and Proton Pump Inhibitor Rabeprazole on the Pharmacokinetics of HMPL-760 Capsules in Healthy Participants","Inclusion Criteria:\n\n1. Participants are fully aware of this study and voluntarily sign the ICF.\n2. Male or female aged 18 to 45 years old (inclusive).\n3. Participant's body mass index (BMI) at screening: 18 kg\u002Fm2 \\\u003C BMI ≤ 29.9 kg\u002Fm2 and weight ≥ 50 kg for males and ≥ 45 kg for females.\n4. Participant is willing and able to comply with the protocol in all aspects.\n\nExclusion Criteria:\n\n1. Known history of any gastrointestinal surgery or any condition that could affect drug absorption (e.g., cholecystectomy, achlorhydria, peptic ulcer disease, gastric\u002Fintestinal surgery or history of resection; prior appendectomy or hernia repair is allowed).\n2. Clinically significant disease within 8 weeks prior to the first dose or clinically significant infection within 4 weeks prior to the first dose.\n3. Clinically significant abnormal findings in physical examination, vital signs, or laboratory tests at screening.\n4. Systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg at screening.\n5. Participants who smoked over 10 cigarettes daily within 3 months before screening.",true,"ALL","18 Years","45 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a single-center, open-label, randomized, four-period, six-sequence study with a planned enrollment of 24 healthy participants. The study consists of a screening period, a dosing period (Cycles 1, 2, 3, and 4), and a follow-up period. Screening must occur within 14 days prior to the first dose of study drug. Enrolled participants will be randomly assigned to one of 6 dosing sequences in the ratio of 1:1:1:1:1:1 to complete Cycles 1-3 dosing to evaluate the effect of different types of food on the PK of HMPL-760, and then to receive rabeprazole and HMPL-760 in Cycle 4 to assess the effect of PPI on the PK of HMPL-760 (see dosing sequence table for details).",[27],"Healthy Participants","NOT_YET_RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-11","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2026-12",{"name":38,"class":39},"Hutchmed","INDUSTRY",1,{"id":42,"slug":43,"hasResults":10,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100610489","phase-1-a-phase-a-study-of-hmpl-a251-in-participants-with-advanced-or-metastatic-her2-expressing-solid-tumors-100610489","NCT07228247","A Phase Ⅰ\u002FⅡa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors","A Phase Ⅰ\u002FⅡa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A251 in Participants With Advanced or Metastatic HER2-Expressing Solid Tumors","Inclusion Criteria:\n\n1. Histologically confirmed unresectable advanced or metastatic disease.\n2. Have at least one measurable lesion per RECIST v1.1;\n3. Life expectancy ≥ 12 weeks;\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;\n5. Weight ≥ 35 kg;\n\nExclusion Criteria:\n\n1. An established diagnosis of type I diabetes mellitus or uncontrolled type II diabetes mellitus.\n2. Use of strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug;\n3. Toxicity from prior anti-tumor therapy has not recovered to Grade 1 or baseline prior to the first dose of study drug (except alopecia). Participants with chronic Grade 2 toxicities may be eligible after discussion between the investigator and Sponsor Medical Monitor (e.g., Grade 2 chemotherapy-induced neuropathy);\n4. Baseline blood amylase or lipase exceeds the normal range and are judged by the investigators to be clinically significant;\n5. Spinal cord compression, leptomeningeal disease, or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;\n6. Major surgery within 28 days prior to the first dose of study drug. Participants must have recovered adequately from the toxicity and\u002For complications from the intervention prior to the first dose of study drug(s);",{"count":49,"type":21},147,[24,51],"PHASE2","This is a first-in-human (FIH), phase Ⅰ\u002FⅡa, open-label, multicenter clinical study of HMPL-A251 monotherapy in adult participants with unresectable, advanced or metastatic HER2-expressing solid tumors.",[54],"Solid Tumors, Adult","RECRUITING","2026-05-25",{"date":58,"type":32},"2026-05-27",{"date":60,"type":32},"2025-12-16",{"date":62,"type":21},"2028-12-31",{"name":38,"class":39},16,{"id":66,"slug":67,"hasResults":10,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100543900","phase-2-a-phase-iiiii-trial-to-evaluate-the-efficacy-and-safety-of-surufatinib-combined-with-camrelizumab-nab-paclitaxel-and-gemcitabine-in-metastatic-pancreatic-cancer-100543900","NCT06361888","A Phase II\u002FIII Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer","A Multicenter, Randomized, Open-label, Active-controlled, Phase II\u002FIII Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n1. Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;\n2. Age range is 18-75 years old (inclusive);\n3. Pancreatic cancer confirmed by histology or cytology;\n4. Stage IV metastasis Pancreatic cancer patients;\n5. Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer;\n6. According to RECIST 1.1, there is at least one measurable lesion;\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;\n8. Expected survival time ≥ 12 weeks;\n\nExclusion Criteria:\n\n1. Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose；\n2. Presence of other malignancies in the past 5 years;\n3. Received major surgical surgery within 4 weeks before the first dose;\n4. Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;\n5. Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;\n6. Received strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;\n7. Use of immunosuppressive drugs within 4 weeks before first dose;\n8. Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;\n9. Patients who currently have hypertension that cannot be controlled by medication;","75 Years",{"count":74,"type":21},502,[51,76],"PHASE3","To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer",[79],"Metastatic Pancreatic Cancer",[81],"First-line treatment in patients",{"date":83,"type":32},"2026-05-28",{"date":85,"type":32},"2024-05-08",{"date":87,"type":21},"2028-05-31",{"name":38,"class":39},2,{"id":91,"slug":92,"hasResults":10,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100624422","phase-3-a-phase-iii-study-of-hmpl-760-plus-r-gemox-vs-placebo-plus-r-gemox-in-relapsedrefractory-dlbcl-100624422","NCT07409428","A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed\u002FRefractory DLBCL","A Phase III Randomized, Double-Blind, Positive Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination With R-GemOx Versus Placebo in Combination With R-GemOx in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Sign the ICF and be able to follow the requirements of study protocol;\n2. Age ≥18 years;\n3. ECOG performance status score between 0 and 2;\n4. Histopathologically confirmed diagnosis of DLBCL;\n5. The investigator judges that the patient's current condition requires further treatment;\n6. Patients should have at least one bi-dimensionally measurable lesion;\n7. Expected survival is more than 12 weeks;\n\nExclusion Criteria:\n\n1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;\n2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;\n3. Organ insufficiency;\n4. Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);\n5. History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;\n6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);\n7. The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria);\n8. Clinically significant active infection;",{"count":98,"type":21},240,[76],"This is a Phase III randomized, double-blind, positive controlled study to evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with R\u002FR DLBCL.",[102],"Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma",[104,105,106],"HMPL-760","R-GemOx (rituximab, gemcitabine, and oxaliplatin)","R\u002FR DLBCL","2026-03-27",{"date":109,"type":32},"2026-04-01",{"date":111,"type":32},"2026-03-20",{"date":113,"type":21},"2028-12-30",{"name":38,"class":39},41,{"id":117,"slug":118,"hasResults":10,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":5},"100623434","phase-1-hmpl-a580-in-participants-with-advanced-or-metastatic-solid-tumor-100623434","NCT07396584","HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor","A Phase I\u002FⅡa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A580 in Participants With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Understood this study and are able to voluntarily sign the informed consent form (ICF);\n2. Male or Female, Age ≥ 18 years;\n3. Histological confirmed, unresectable, advanced or metastatic solid tumor\n4. Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1\n5. Life expectancy ≥ 12 weeks\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n\nExclusion Criteria:\n\n1. An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus\n2. Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug\n3. Major surgery within 28 days prior to the first dose of study drug\n4. Active infection requiring systemic treatment\n5. Participant has received a live within 3 months before study enrollment\n6. History of inflammatory gastrointestinal diseases\n7. Known hypersensitivity to any component of HMPL-A580\n8. Pregnant (positive pregnancy test) or lactating;",{"count":124,"type":21},186,[24,51],"This is a first-in-human, multicenter, open-label, phase I\u002FⅡa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors.",[54],"2026-03-24",{"date":107,"type":32},{"date":131,"type":21},"2026-03-04",{"date":133,"type":21},"2029-01-30",{"name":38,"class":39},{"id":136,"slug":137,"hasResults":10,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":40},"100389630","phase-2-hmpl-453-tartrate-in-advanced-intrahepatic-cholangiocarcinoma-100389630","NCT04353375","HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma","An Open-Label, Single-Arm, Multicenter Phase 2\u002F3b Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Habouring FGFR2 Fusion\u002FRearrangement","Inclusion Criteria:\n\n1. Have fully understood the study and voluntarily signed the ICF;\n2. Age ≥ 18 years;\n3. a. pathologically or cytologically confirmed advanced treatment failure solid tumor with standard patients (applicable to cohorts2 stage I); b. histologically or cytologically confirmed histologically or cytologically confirmed locally advanced unresectable or metastatic ICC patients with FGFR2 fusions\u002Frearrangements\u002Fmutation (applicable to Cohort 1, Cohort 2 Stage II, Cohort 3 and Cohort 4)\n4. a. The patients have received at least one prior systemic treatment regimen for advanced ICC and has intolerable PD or toxicity(Cohort1-3); b. Patients who have not received any prior systemic therapy for advanced ICC(Cohort4)\n5. Measurable lesion according to RECIST v1.1;\n6. ECOG performance status of 0 or 1;\n7. Life expectancy ≥ 12 weeks;\n8. Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol.\n\nExclusion Criteria:\n\n1. Patients who previously received selective FGFR targeting therapy;\n2. Received approved or researched systemic anti-tumor treatment within 3 weeks prior to the start of the study treatment;\n3. Radical radiotherapy within 4 weeks;\n4. Have received local anti-tumor treatment within 4 weeks;\n5. Major surgery requiring hospitalization or incomplete healing of the surgery incision within 4 weeks;\n6. Current or prior history of retinal detachment;\n7. Using a strong inducer or inhibitor of cytochrome P450 3A (CYP3A) within 2 weeks or 5 half-lives of the study treatment;\n8. Taking drugs or dietary supplementsthat may cause blood phosphorus and\u002For blood calcium to rise within 2 weeks prior to the start of the study treatment;\n9. International normalized ratio above 1.5 or partial activated prothrombin time above 1.5 times ULN;\n10. History of clinically significant active hepatopathy, including active viral hepatitis, or other active hepatitis, clinically significant moderate to severe liver cirrhosis;\n11. The patients with human immunodeficiency virus (HIV) infection;\n12. Active infection requiring systemic treatment within 1 week prior to the start of the study treatment;\n13. Screening blood phosphorus levels above ULN, or history of abnormal calcium phosphorus metabolism requiring clinical intervention or relevant medical history;\n14. Currently keratopathy confirmed by ophthalmological examination;\n15. Prior history of retinal detachment, or current diseases that may cause retinal detachment;\n16. Clinically significant arrhythmia or conduction abnormalities requiring clinical intervention;\n17. Patients with known deep venous thrombosis, treated with low molecular weight heparin (LMWH) or drugs with similar efficacy, and the investigator judges that the thrombosis is stable for ≥ 2 weeks ;\n18. Toxicities caused by prior anti-tumor treatment have not recovered to grade 0 or 1;\n19. The patient has any current disease or condition that affects drug absorption, or the patient cannot be orally administered;\n20. Combined with other malignant tumor or a history of other malignant tumor within 5 years prior to study screening;\n21. Patients currently has central nervous system metastases, meningeal metastases or spinal cord compression, except in individual cases;\n22. Any other medical condition or clinically significant laboratory abnormalities judged by the investigator would make the patients unsuitable to participate in this study.",{"count":143,"type":21},235,[51,76],"The goal of this clinical trial is to evaluate in patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusion\u002Frearrangement. The main questions it aims to answer are:\n\nTo evaluate the objective response rate (ORR) of HMPL-453 tartrate in the treatment of patients with advanced intrahepatic cholangiocarcinoma (ICC) habouring fibroblast growth factor receptor (FGFR) 2 fusions\u002Frearrangements after at least one line of systemic treatment failure or intolerance Participants will receive HMPL-453 tartrate 300 mg QD orally (for 14 consecutive days \\[Days 1 to 14\\] followed by 7 days off \\[Day 15 to 21\\], 21 days as a treatment cycle.\\]",[147,148],"Advanced Intrahepatic Cholangiocarcinoma","Solid Tumor, Adult",[150,151,152],"FGFR2 funsion","HMPL-453","ICC","2025-12-25",{"date":155,"type":32},"2025-12-31",{"date":157,"type":32},"2020-09-03",{"date":159,"type":21},"2030-02-28",{"name":38,"class":39},{"id":162,"slug":163,"hasResults":10,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":64},"100545835","phase-1-a-clinical-study-of-hmpl-506-in-patients-with-hematological-malignancies-100545835","NCT06387082","A Clinical Study of HMPL-506 in Patients With Hematological Malignancies","A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HMPL-506 in Patients With Hematological Malignancies","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria to be eligible for enrolment.\n\n  1. Having understood this study adequately and being voluntary to sign the ICF;\n  2. Age ≥18 years;\n  3. 1\\) Dose escalation phase: patient with MLL-rearranged and\u002For NPM1-mutant relapsed\u002Frefractory AML or ALL (confirmed as per the 2022 World Health Organization (WHO) Classification of Myeloid Neoplasms and Acute Leukemia): 2) Dose expansion phase: approximately 10 to 20 patients will be enrolled in each of the following cohorts\n\n     * MLL-rearranged and\u002For NPM1-mutant relapsed\u002Frefractory AML\n     * MLL-rearranged relapsed\u002Frefractory ALL\n     * Relapsed\u002Frefractory MM (which can be screened and enrolled without biomarker testing), and AML harboring genetic alterations such as NUP214 or NUP98 fusion\n  4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2;\n  5. Agree to undergo bone marrow aspiration and\u002For biopsy before and during treatment;\n  6. Women patients of childbearing potential must agree to use highly effective contraceptive methods from screening until 30 days after discontinuation of study treatment, and their male partners must use condoms. See Appendix 11 (Definition of Women of Childbearing Potential \\[WOCBP\\] and Acceptable and Unacceptable Contraceptive Methods) for more details. And women patients of childbearing potential should agree not to donate eggs (or oocytes) for reproductive purposes during this period.\n  7. Male patients with a female partner of childbearing potential must agree to use condoms when having intercourse during the study and within 30 days after discontinuation of the investigational product. Patients should avoid sperm donation or freezing of sperm during the study and within 30 days after discontinuation of the investigational product.\n\nExclusion Criteria:\n\n* Subjects will be excluded from this study project if they meet any of the following criteria:\n\n  1. Patients who have previously received treatment with menin inhibitors and experienced progression during treatment;\n  2. Patients with definite active central nervous system (CNS) leukemia (prior CNS leukemia has been treated and controlled, but a cerebrospinal fluid test through lumbar puncture is required at screening to confirm the absence of CNS involvement);\n  3. Serum total bilirubin (TBIL) \\> 1.5 × the upper limit of normal (ULN), with the exception of the following patients:\n\n     • Patients with Gilbert's disease, with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and serum TBIL ≤ 3 × ULN\n  4. ALT or AST \\> 3 × ULN in the absence of liver involvement with leukemia or ALT or AST \\> 5 × ULN in the presence of liver involvement with leukemia (the latter criterion is not applicable in the dose escalation phase);\n  5. Glomerular filtration rate or creatinine clearance estimated using Cockcroft-Gault formula \\\u003C 50 mL\u002Fmin.\n  6. International normalized ratio (INR) \\> 1.5 × ULN or activated partial thromboplastin time (aPTT) \\> 1.5 × ULN; this criterion is not applicable in patients who are receiving anticoagulant therapy.\n  7. Known history of clinically significant liver disease, including viral hepatitis or other types of hepatitis:\n\n     * Patients with hepatitis B (HBV) (HBsAg or HBcAb positive) can be enrolled if they test negative for HBV DNA by PCR, but the HBV DNA test should be performed every cycle\n     * Patients with hepatitis C (HCV) can be enrolled if they test negative for HCV RNA by PCR.\n  8. Known human immunodeficiency virus (HIV) infection.\n  9. Women who are pregnant (with a positive pregnancy test before administration) or breastfeeding.\n  10. History of stroke or intracranial hemorrhage within 6 months prior to the first dose of the investigational product.\n  11. Patients with other primary malignancies within the last 5 years, but patients with the following non-invasive tumors that have been treated with curative intent are exceptions: basal cell carcinoma of skin, squamous cell carcinoma of skin, in situ carcinoma of cervix and breast cancer in situ.\n  12. Patients who meet any of the following cardiac function-related criteria:\n\n      * Any clinically significant abnormal heart rhythm or conduction requiring clinical intervention.\n      * Hereditary long QT syndrome or QTcF \\> 470 msec.\n      * Clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or above congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C 50%, or uncontrolled hypertension (systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg), or mean heart rate \\> 100 beats\u002Fmin on triplicate electrocardiograms (ECGs) at screening.\n  13. Receipt of systemic anti-tumor therapy or radiotherapy within 2 weeks prior to initiation of study treatment:\n\n      * For patients with increased peripheral white blood cell count (WBC \\> 25 × 109\u002FL), use of hydroxycarbamide is allowed to control peripheral WBC before enrollment and during HMPL-506 treatment.\n      * Prophylactic intrathecal injection of chemotherapy drugs (cytarabine, dexamethasone and methotrexate) to prevent CNS leukemia is allowed.\n  14. Patients who have received HSCT within 60 days before initiation of study treatment, or are receiving immunosuppressive therapy after HSCT at screening, or require medical intervention to control graft versus host disease (GVHD):\n\n      • Patients who use fixed-dose oral glucocorticoids and\u002For topical glucocorticoids for the treatment of skin GVHD can be enrolled.\n  15. Patients who have received treatment with herbal and traditional medicines\u002Ftheir active ingredients with definite anti-tumor activity within 1 week before initiation of study treatment.\n  16. Use of potent inducers or inhibitors of CYP3A4 within 2 weeks (3 weeks for St John's wort) or 5 half-lives (whichever is longer) before initiation of study treatment.\n  17. An interval of less than 2 weeks from the last dose of any small molecular drug or of less than 4 weeks from the last dose of any macromolecular drug (e.g., antibody drugs) administered during previous participation in other drug clinical trials before treatment initiation in this study.\n  18. Patients who have undergone major surgery within 4 weeks prior to the first dose of the investigational product.\n  19. Toxicities from previous anti-tumor treatments have not yet recovered to Grade ≤ 1 (excluding alopecia).\n  20. Patients with uncontrolled active infection requiring hospitalization or intravenous antibiotics (defined as persistent signs\u002Fsymptoms related to the infection without improvement despite receipt of appropriate anti-infection therapy and\u002For other treatments); or unexplained pyrexia with a temperature above 38.5℃ during the screening period (only patients with tumor fever as judged by the investigator can be enrolled);\n\n      • Patients with neutropenia who, in the opinion of the investigator, require prophylactic intravenous antibiotics can be enrolled\n  21. Presence of conditions that may affect the absorption of the investigational product as judged by the investigator, such as inability to take drugs orally, past surgery history or severe gastrointestinal diseases including dysphagia and active gastric ulcer.\n  22. Patients with poor compliance who are judged by the investigator as not suitable for participation in this clinical study.\n  23. Any other disease, metabolic abnormality, physical examination abnormality or clinically significant laboratory test abnormality, based on which the investigator has reason to suspect that the patient has certain disease or condition that is not suitable for treatment with the investigational product, or that will affect the interpretation of study results or will put the patient at high risk.",{"count":169,"type":21},132,[24],"This is a Phase 1, multicenter, open-label clinical study of HMPL-506 administered orally in the treatment of hematological malignancies. Only eligible patients who provide the signed informed consent form (ICF) can be enrolled in this study. The study consists of two phases, i.e., a dose escalation phase and a dose expansion phase. The study is expected to enroll approximately 60 to 132 patients, including approximately 30 to 38 patients in the dose escalation phase and approximately 30 to 72 patients in the dose expansion phase.",[173],"Hematological Malignancies","2025-09-26",{"date":176,"type":32},"2025-09-29",{"date":178,"type":32},"2024-05-27",{"date":180,"type":21},"2027-12-08",{"name":38,"class":39},{"id":183,"slug":184,"hasResults":10,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"100545834","phase-3-a-study-to-evaluate-hmpl-306-in-patients-with-idh1or-idh2-mutated-acute-myeloid-leukemia-100545834","NCT06387069","A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia","A Multicenter, Randomized, Open-Label, Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-306 vs. Salvage Chemotherapy Regimens in Patients With IDH1- and IDH2-mutated Relapsed\u002FRefractory Acute Myeloid Leukemia (R\u002FR AML)","Inclusion Criteria:\n\n1. Have signed the ICF;\n2. Be able to follow the requirements of study protocol;\n3. Age ≥18 years;\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2;\n5. Cohort 1: Patients with R\u002FR primary AML harboring IDH1-R132 site mutation \\[WHO 2022 Classification Criteria for Myeloid Neoplasms and Acute Leukemia, with the exception of APL (AML-M3) and extramedullary recurrence of leukemia alone without bone marrow involvement\\]; Cohort 2: Patients with R\u002FR primary AML harboring IDH2-R140\u002FR172 mutations \\[WHO 2022 Classification Criteria for Myeloid Neoplasms and Acute Leukemia, with the exception of APL (AML-M3) and recurrence of extramedullary leukemia alone without bone marrow involvement\\]. A patient with both IDH1 and IDH2 mutations will be included in Cohort 2 (IDH2 mutation group);\n6. Agree to undergo bone marrow aspiration and\u002For biopsy before and during treatment;\n7. Be willing to complete QoL assessments at specified time points during study treatment and after treatment discontinuation;\n8. Female patients of childbearing potential must agree to use highly effective contraceptive methods during the study and within 30 days after discontinuation of the study drug (the time limit of contraception for the chemotherapy group needs to be extended to 6 months after the last dose) (see Appendix 9 (contraception requirements) for more information), and agree not to donate eggs (oocytes) for reproductive purposes during this period; patients must not be lactating and must have a negative pregnancy test (if of childbearing potential);\n9. Male patients with female partners of childbearing potential must use condoms during intercourse and avoid donating or freezing sperm during the study and within 30 days after discontinuation of the study drug (the time limit of contraception for the chemotherapy group needs to be extended to 6 months after the last dose).\n10. Predicted survival greater than 12 weeks as assessed by the investigator.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria must be excluded:\n\n1. Patients who received prior treatment with IDH1 inhibitors, IDH2 inhibitors, or IDH1\u002FIDH2 dual target inhibitors;\n2. Patients with known RAS or FLT3 hotspot mutations (patients who have test results definitely switched to negative at the time of enrollment can be enrolled);\n\n   Hotspot mutations include:\n\n   KRAS mutations: G12 or G13 (exon 2); Q61 (exon 3) NRAS mutations: G12 or G13 (exon 2); Q61 (exon 3) FLT3 mutations: ITD; TKD (D835 or I836)\n3. Inadequate organ function, as defined below:\n\n   * Serum total bilirubin (TBIL) higher than 1.5 times the upper limit of normal (ULN), excluding the following patients:\n\n     \\- Patients with Gilbert's disease, with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and serum TBIL ≤ 3 × ULN.\n   * AST or ALT \\> 2.5 × ULN (if leukemia invades the liver, patients with AST and ALT levels ≤ 5 × ULN can be enrolled);\n   * Estimated creatinine clearance by Cockcroft-Gault formula \\\u003C 50 mL\u002Fmin or creatinine \\> 1.5 × ULN;\n4. International Normalized Ratio (INR) \\> 1.5 × ULN or activated partial thromboplastin time (aPTT) \\> 1.5 × ULN, except for patients who are receiving anticoagulant therapy;\n5. Blood amylase \\> 1.5 × ULN and assessed to be clinically significant by the investigator;\n6. Current known history of liver disease, including cirrhosis, alcoholic liver disease, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV):\n\n   * Patients who are positive for serum hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) are required to undergo HBV deoxyribonucleic acid (DNA) testing, and patients with HBV DNA test results that are either negative or below the lower limit of normal at the site can be enrolled;\n   * Patients with positive HCV serology may be enrolled only if the HCV ribonucleic acid (RNA) test is negative or below the lower limit of normal at the site;\n7. Known human immunodeficiency virus (HIV) infection;\n8. Meet any of the following cardiac function-related criteria:\n\n   * Any clinically significant rhythm or conduction abnormalities requiring clinical intervention;\n   * Clinically significant cardiovascular diseases that require clinical intervention as judged by the investigator, including but not limited to: acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting within 6 months prior to randomization, New York Heart Association (NYHA) Class II (inclusive) or above congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C 45%, or uncontrolled hypertension after medication (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg);\n   * Congenital long QT syndrome or QTcF \\>470 msec in females\u002FQTcF \\>450 msec in males;\n   * Use of drugs currently known to cause QT prolongation (Appendix 5); patients who have switched the medication by 5 half-lives of the drug prior to the dosing of the study drug or have their ECG to be regularly monitored during the study (QTcF is required to be regularly monitored if no medication is available for replacement) could be enrolled.\n9. Patients with other primary malignancies within the last 5 years, except for patients who have been cured, and patients with the following non-invasive tumors who have been treated with definitive treatment:\n\n   * Basal cell carcinoma of skin\n   * Squamous cell carcinoma of skin and cervix\n   * Carcinoma in situ of cervix\n   * Breast cancer in situ\n10. Pregnant (positive pregnancy test prior to treatment) or lactating women;\n11. Patients with childbearing requirements;\n12. History of stroke or intracranial hemorrhage within 6 months prior to randomization;\n13. Patients who have undergone major surgery within 4 weeks prior to randomization;\n14. Patients who have received any monoclonal antibody for anti-tumor therapy within 3 weeks or 2 half-lives prior to randomization, whichever is longer;\n15. Patients who have received treatment with the investigational product or investigational device in a clinical study within 3 weeks prior to randomization;\n16. Patients who have received anti-tumor treatment (chemotherapy, targeted therapy, immunotherapy, or anti-tumor vaccine, etc,) within 3 weeks prior to randomization or received radiotherapy within 3 months prior to randomization; patients who have received CAR-T therapy within 4 weeks prior to randomization; patients who have received HSCT within 60 days prior to randomization, or are receiving immunosuppressive therapy after HSCT at screening, or are accompanied by graft-versus-host disease (GVHD) requiring drug control; patients undergoing treatment for skin graft-versus-host disease (GVHD) with fixed oral doses of and\u002For topical corticosteroids may be enrolled only if they can benefit from the study treatment as assessed by the investigator; for patients receiving prophylactic intrathecal administration of chemotherapy drugs (cytarabine, dexamethasone and methotrexate) to prevent central leukemia, no washout is required;\n17. Central nervous system leukemia: patients with clinical symptoms suggesting active central nervous system (CNS) leukemia or confirmed CNS leukemia invasion;\n18. Patients who have received live vaccines within 4 weeks prior to randomization;\n19. Use of traditional Chinese medicine with anti-tumor effect within 1 week prior to randomization;\n20. Patients with uncontrolled active systemic fungal, bacterial, or viral infection (defined as persistent signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotic or antiviral therapy and\u002For other treatments), or persistent unexplained pyrexia (\\> 38.5℃) without improvement during the screening period (only patients with tumor fever as judged by the investigator can be enrolled);\n21. Inability to take medications orally, past surgery history or severe gastrointestinal diseases including dysphagia, active gastric ulcer, etc., which may interfere with the absorption of study drug as judged by the investigator;\n22. Insufficient compliance in participating in this clinical study as judged by the investigator;\n23. Toxicities from previous anti-tumor treatments have not yet recovered to Grade ≤ 1 (excluding alopecia);\n24. Patients with any other disease, metabolic abnormality, physical examination abnormality or clinically significant laboratory test abnormality, based on which the investigator has reason to suspect that the patient has certain disease or condition that is not suitable for treatment with the investigational product, or that will affect the interpretation of study results or will put the patient at high risk.",{"count":190,"type":21},316,[76],"This study is a multicenter, randomized, open-label, phase III clinical study (RAPHAEL) to evaluate the efficacy, safety, and PK of HMPL-306 versus salvage chemotherapy in patients with R\u002FR AML harboring IDH1 and IDH2 mutations.",[194],"Acute Myeloid Leukemia",[194,196],"IDH","2025-08-11",{"date":199,"type":32},"2025-08-14",{"date":201,"type":32},"2024-04-26",{"date":203,"type":21},"2029-09-30",{"name":38,"class":39},53,{"id":207,"slug":208,"hasResults":10,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":40},"100594866","phase-1-phase-i-study-of-hmpl-306-for-the-treatment-of-gliomas-with-idh1-andor-idh2-mutations-100594866","NCT07025018","Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and\u002For IDH2 Mutations","A Multicenter, Randomized Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of HMPL-306 in Patients With Gliomas Harboring IDH1 and\u002For IDH2 Mutations","Inclusion Criteria:\n\n1. Fully informed about the study and voluntarily sign the informed consent form (ICF).\n2. Age ≥ 18 years.\n3. Safety Lead-In Phase: Patients with gliomas of a documented IDH1 and\u002For IDH2 mutation. Perioperative Study Phase: Patients with gliomas of definitive or suspected IDH1 and\u002For IDH2 mutations scheduled for surgery.\n4. All patients must have at least one measurable lesion.\n5. Karnofsky Performance Status (KPS) score ≥ 80% .\n6. In the investigator's judgment, a life expectancy of ≥ 12 weeks.\n7. Sufficient bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Previous treatment with IDH inhibitors.\n2. Unresolved toxicity from previous antitumor treatments not reverted to ≤ Grade 1 (except for alopecia, skin pigmentation changes, and ≤ Grade 2 peripheral neuropathy).\n3. Patients assessed by researchers to have high-risk or unstable conditions.\n4. Having other malignancies or a history of other malignancies within 5 years prior to screening.\n5. History of clinically significant liver disease, including active infection with viral hepatitis, or other active hepatitis, alcoholic liver disease, cirrhosis, etc.\n6. Patients with HIV infection.\n7. Pregnancy (positive pregnancy test before dosing) or currently breastfeeding women.\n8. Presence of diseases or conditions affecting drug absorption.\n9. Any other conditions, in the investigator's judgment, unsuitable for the study drug, will result in exclusion.",{"count":214,"type":21},52,[24],"This study is a multicenter, randomized controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1 and\u002For IDH2 mutations",[218],"Gliomas Harboring IDH1 and\u002For IDH2 Mutations",[220,221,222,223,224,225,226,227,228,229,230,231,232,233],"gliomas","randomized controlled","Multicenter","IDH1 mutations","IDH2 mutations","safety run-in","MRI\u002FMRS examination","Phase I","clinical study","pharmacokinetics (PK)","pharmacodynamics (PD)","efficacy","HMPL-306","perioperative study","2025-07-31",{"date":236,"type":32},"2025-08-01",{"date":238,"type":32},"2025-07-15",{"date":240,"type":21},"2027-12",{"name":38,"class":39},{"id":243,"slug":244,"hasResults":10,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":10,"sex":249,"minAge":17,"maxAge":72,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},"100560967","phase-3-study-of-fruquintinib-plus-sintilimab-for-treatment-of-advanced-endometrial-cancer-100560967","NCT06584032","Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer","A Randomized,Open-label,Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab Versus Chemotherapy of the Treating Physician's Choice as Second-line Treatment for Advanced Endometrial Cancer","Inclusion Criteria:\n\n1. Have fully understood and voluntarily signed the informed consent form\n2. Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg\u002Fm\\^2;\n3. Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions\n4. Patients who previously failed first-line systemic platinum-based therapy\n5. ECOG PS (Eastern Cooperative Oncology Group performance status score) 0 or 1;\n6. Need to provide tumor samples for central lab testing of biomarkers such as MSI(microsatellite instability) status;\n7. Non-MSI-H(non-microsatellite instability-high) by central lab or previous test result indicating pMMR(proficient mismatch repair);\n8. Adequate function of the major organs;\n9. Expected survival ≥ 12 weeks;\n10. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization.\n\nExclusion Criteria:\n\n1. Endometrial carcinosarcoma or sarcoma;\n2. Known MMR(mismatch repair)\u002FMSI status with dMMR(deficient mismatch repair) or MSI-H(microsatellite instability-high);\n3. Toxicities related to prior anticancer therapy did not recover to ≤CTCAE Grade 1, except alopecia and oxaliplatin-induced peripheral neurotoxicity ≤CTCAE Grade 2;\n4. Received systemic anti-tumor therapy approved within 4 weeks before randomization;\n5. Other malignancies within the past 5 years;\n6. Previous or screening central nervous system (CNS) metastases;\n7. Radical radiotherapy within 4 weeks before randomization\n8. Previously received any anti-programmed cell death receptor-1 (PD-1) antibody, anti-PD-L1(programmed death ligand-1) antibody, anti-PD-L2(programmed death ligand-2) antibody, or anti cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody acting on T cell costimulation or checkpoint pathways (eg, OX40, CD137, etc) or small molecule vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors;\n9. Symptomatic or treatment-requiring thyroid dysfunction at screening;\n10. Use of immunosuppressive agents within 4 weeks before randomization\n11. Presence of any active autoimmune disease requiring systemic treatment or history of autoimmune disease within the past 2 years;\n12. Systemic immunostimulants within 4 weeks before randomization;\n13. Administration of any live or live-attenuated vaccine within 4 weeks before randomization or planned during the study;\n14. Major surgical procedures within 4 weeks before randomization;\n15. Uncontrolled malignant pleural effusion, ascites or pericardial effusion;\n16. Patients with current hypertension uncontrolled by medication;\n17. Patients with any current disease or condition affecting drug absorption, or patients unable to take oral medications;\n18. Receiving strong inducers of cytochrome P450 3A4 enzyme;\n19. Patients with gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; or with gastrointestinal perforation or gastrointestinal fistula, which is not recovered after surgical treatment;\n20. Active bleeding within 3 weeks before randomization, or melena, or bleeding from a tumor within 2 weeks before the first dose ;\n21. Tumor invading major vascular structures and is judged by the investigator to be at greater risk of massive haemorrhage;\n22. Patients who had arterial thrombosis or deep venous thrombosis within 6 months before randomization; or patients who had stroke events and\u002For transient ischemic attack within 12 months; patients who had thrombosis caused by implantable intravenous infusion pump or catheter, except patients who had stable thrombosis after conventional anticoagulant therapy;\n23. Clinically significant cardiovascular disease;\n24. Clinically significant electrolyte abnormalities as judged by the investigator;\n25. Active infection or fever of unknown origin before randomization;\n26. Patients with active pulmonary tuberculosis (TB) receiving anti-tuberculosis treatment or anti-tuberculosis treatment within 1 year before randomization;\n27. Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, which may interfere with the detection and management of suspected drug-related pulmonary toxicity; previous or current (non-infectious) pulmonary inflammation requiring steroid hormone therapy;\n28. Positive human immunodeficiency virus (HIV) antibody screening;\n29. Known history of clinically significant liver disease\n30. Known hypersensitivity to any of the study drugs or any of their excipients, or previous history of serious hypersensitivity to any other monoclonal antibody;\n31. Patients who have received other clinical drugs that have not been approved or marketed within 4 weeks before randomization;\n32. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n33. Patients who have received tissue\u002Forgan transplantation;\n34. Patients with known psychiatric disorders or substance abuse disorders that could affect study compliance;\n35. Patients who, in the opinion of the investigator, have other reasons that would make them inappropriate for this clinical study.","FEMALE",{"count":251,"type":21},412,[76],"The goal of this study is to evaluate whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).",[255],"Advanced Endometrial Cancer",[257,258,259],"fruquintinib","sintilimab","endometrial cancer","2025-01-05",{"date":262,"type":32},"2025-01-07",{"date":264,"type":32},"2024-12-12",{"date":266,"type":21},"2029-06-09",{"name":38,"class":39},17,{"id":270,"slug":271,"hasResults":10,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":40},"100507360","phase-1-a-study-of-hmpl-415s1-in-patients-with-advanced-malignant-solid-tumors-100507360","NCT05886374","A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors","A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-415S1 in Patients With Advanced Malignant Solid Tumor","Inclusion Criteria:\n\nAll the following conditions must be met for enrollment:\n\n1. Fully understand this study and voluntarily sign the ICF;\n2. Dose escalation Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons; Dose expansion phase: Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons, carrying aberrant activating mutations in the KRAS pathway；\n3. Presence of at least one measurable lesion (RECIST 1.1 criteria);\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 point;\n5. Life expectancy ≥ 12 weeks as judged by the investigator;\n6. Male of childbearing potential and their heterosexual partners of childbearing potential must agree to use effective methods of contraception.\n\nExclusion Criteria:\n\nA patient may not participate in this study if any of the following conditions apply:\n\n1. Patients who priorly received SHP2 inhibitors;\n2. Receiving the approved systemic antitumor treatment within 4 weeks prior to the first dose, including: chemotreatment, targeted treatment, immunization treatment, biological treatment, etc. (wash-out for 2 weeks for hormone treatment or traditional chinese medicine and chinese patent medicine with clear antitumor indications);\n3. Have been in the treatment period of other interventional clinical studies (including small molecule chemicals and large molecule antibodies) within 4 weeks prior to the first dose. If participating in a non-interventional clinical study (eg, epidemiological study), you can enroll in this study; if already in the survival follow-up period of an interventional clinical study, you can enroll in this study.\n4. Major surgery or radical radiotreatment (except palliative radiotreatment for metastases to bone lesions) within 4 weeks prior to first dose.\n5. Central nervous system (CNS) malignant tumor or known CNS metastasis;\n6. Having multiple factors that affect the absorption, distribution, metabolism or excretion of orally administered drugs (such as inability to swallow drugs, frequent vomiting, chronic diarrhoea, etc.);\n7. Any other disease, metabolic abnormality, physical examination abnormal, or clinically significant laboratory test abnormality that, in the judgment of the investigator, would compromise patient compliance or give reason to suspect that the patient has a disease or condition that would compromise the interpretation of study results or place the patient at high risk.",{"count":277,"type":21},81,[24],"The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-415S1 and determine MTD and\u002For RP2D in patients with advanced malignant solid tumor.",[281],"Advanced Malignant Solid Tumors","2023-07-19",{"date":284,"type":32},"2023-07-21",{"date":286,"type":32},"2023-07-06",{"date":288,"type":21},"2026-06-30",{"name":38,"class":39},""]