An Open-Label, Single-Arm, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusion/Rearrangement
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 harboring 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.\]
• Signed the informed consent form;
• Age ≥ 18 years;
• Patients with histologically or cytologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements;
• Patients have received at least one prior systemic treatment regimen for advanced intrahepatic cholangiocarcinoma and have intolerable PD or toxicity ;
• Measurable lesion according to RECIST v1.1, refer to the protocol
• ECOG performance status of 0 or 1;
• Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol.