HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma
Trial Parameters
Brief Summary
The goal of this clinical trial is to evaluate in patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusion/rearrangement. The main questions it aims to answer are: To 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/rearrangements 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.\]
Eligibility Criteria
Inclusion Criteria: 1. Have fully understood the study and voluntarily signed the ICF; 2. Age ≥ 18 years; 3. 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/rearrangements/mutation (applicable to Cohort 1, Cohort 2 Stage II, Cohort 3 and Cohort 4) 4. 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) 5. Measurable lesion according to RECIST v1.1; 6. ECOG performance status of 0 or 1; 7. Life expectancy ≥ 12 weeks; 8. Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol. Exclusion Cri