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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
HMPL-453
DrugCohort\_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)
Treatment groups
235 Participants
are divided into 1 treatment groupGroup A: HMPL-453Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
Proportion of patients whose best overall response are confirmed CR or PR
Time frame
Measured up to 6 months after the last patient has been enrolled or all patients have finished their last PFS follow up, whichever comes firstSecondary outcomes
1
Disease control rate (DCR)
Proportion of patients whose best overall response after treatment is confirmed CR or PR, or judged as SD (SD≥6 weeks)
Time frame
Measured up to 6 months after the last patient has been enrolled or all patients have finished their last PFS follow up, whichever comes first2
Time to response (TTR)
The time from the first dose of study drug to the first CR or PR in patients whose best overall response is a confirmed CR or PR
Time frame
Measured up to 6 months after the last patient has been enrolled or all patients have finished their last PFS follow up, whichever comes first3
Duration of response (DoR)
The time from initial CR or PR to PD or death from any cause, whichever comes first, in patients whose best overall response is a confirmed CR or PR
Time frame
Measured up to 6 months after the last patient has been enrolled or all patients have finished their last PFS follow up, whichever comes first4
Progression-Free Survival (PFS)
The time from the first study treatment to the onset of PD or death from any cause
Time frame
Measured up to 6 months after the last patient has been enrolled or all patients have finished their last PFS follow up, whichever comes first Source ClinicalTrials.gov