drugset / Trial / NCT04353375

HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma

NCT04353375

Phase 2/3 Recruiting 235 enrolled Hutchmed
NaSingle-groupOpen-labelTreatment

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.\]

Timeline

Start
2020-09-03
Primary completion
2028-06-30
Completion
2030-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject HMPL-453 Unknown 150 mg Oral
Subject HMPL-453 Unknown 300 mg Oral