RecruitingPhase 2Phase 3NCT04353375

HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma

An Open-Label, Single-Arm, Multicenter Phase 2/3b Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Habouring FGFR2 Fusion/Rearrangement

Sponsor

Hutchmed

Enrollment

235 participants

Start Date

Sep 3, 2020

Study Type

INTERVENTIONAL

Conditions

Solid Tumor, Adult Advanced Intrahepatic Cholangiocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called HMPL-453 in patients with advanced bile duct cancer (intrahepatic cholangiocarcinoma, or ICC) that has a specific genetic change involving the FGFR2 gene. HMPL-453 targets the FGFR pathway — a molecular switch that drives tumor growth in some cancers — and may slow or stop tumor growth. **You may be eligible if:** - You are 18 years or older - You have confirmed advanced ICC with FGFR2 gene fusion, rearrangement, or mutation (for most groups), or another solid tumor that has failed standard treatments (for one group) - Your cancer can be measured on scans - You are in reasonably good health - Depending on the study group: you have received at least one prior treatment for advanced ICC, OR you have not yet received any systemic treatment for advanced ICC **You may NOT be eligible if:** - You have certain heart, eye, or liver conditions that could be worsened by the drug - You do not have the required FGFR2 genetic changes (for most groups) - You do not meet organ function requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHMPL-453

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)