drugset / Trial / NCT04353375
HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HMPL-453 | Unknown | 150 mg | Oral |
| Subject | HMPL-453 | Unknown | 300 mg | Oral |