HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHutchmed
About this trial
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 criteria
Qualifiers
Have fully understood the study and voluntarily signed the ICF;
Age ≥ 18 years;
a. pathologically or cytologically confirmed advanced treatment failure solid tumor with standard patients (applicable to cohorts2 stage I); b. histologically or cytologically confirmed histologically or cytologically confirmed locally advanced unresectable or metastatic ICC patients with FGFR2 fusions/rearrangements/mutation (applicable to Cohort 1, Cohort 2 Stage II, Cohort 3 and Cohort 4)
a. The patients have received at least one prior systemic treatment regimen for advanced ICC and has intolerable PD or toxicity(Cohort1-3); b. Patients who have not received any prior systemic therapy for advanced ICC(Cohort4)
Disqualifiers
Patients who previously received selective FGFR targeting therapy;
Received approved or researched systemic anti-tumor treatment within 3 weeks prior to the start of the study treatment;
Radical radiotherapy within 4 weeks;
Have received local anti-tumor treatment within 4 weeks;
Trial design
Treatments tested in this trial
- HMPL-453
Treatment groups
235 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov