[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100389630":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":19,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":19,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":19,"enrollmentInfo":60,"targetDuration":19,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Hutchmed","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HMPL-453","EXPERIMENTAL","HMPL-453 150mg QD HMPL-453 300mg QD",[13],"Drug: HMPL-453",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Cohort\\_1:HMPL-453 150mg QD continuously in 21-day cycles; Cohort\\_2, Cohort\\_3 and Cohort\\_4:HMPL-453 tartrate 300 mg QD orally (for 14 consecutive days \\[Day 1 to 14\\], followed by 7 days off \\[Day 15 to 21\\], 21 days as a treatment cycle)",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Jianming Xu, PhD","Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Bo Zhang","CONTACT","+86 21 2067 1819","boz@hutch-med.com",[32],{"facility":23,"status":33,"city":34,"state":35,"zip":19,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.39723,39.9075,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":47,"phoneExt":19,"email":48},"Jianming Xu","+86 010-68182255","jmxu2003@163.com",{"type":50,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100389630","phase-2-hmpl-453-tartrate-in-advanced-intrahepatic-cholangiocarcinoma-100389630",false,"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.","ALL","18 Years",{"count":61,"type":62},235,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE2","PHASE3","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.\\]",[69,70],"Advanced Intrahepatic Cholangiocarcinoma","Solid Tumor, Adult",[72,9,73],"FGFR2 funsion","ICC","2025-12-25",{"date":76,"type":77},"2025-12-31","ACTUAL",{"date":79,"type":77},"2020-09-03",{"date":81,"type":62},"2030-02-28",{"name":5,"class":6},1]