Clinical Trial

HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma

Recruiting Phase 2/3
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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.\]
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2020-04-16; most recent amendment 2025-12-25.
Status change: Not Yet Recruiting → Recruiting 2023-07-03
Trial Details
NCT Number NCT04353375
Lead Sponsor Hutchmed
Conditions Advanced Intrahepatic Cholangiocarcinoma, Solid Tumor, Adult
Enrollment 235 participants
Start Date 2020-09-03
Primary Completion 2028-06-30 (estimated)
Study Completion 2030-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-12-31