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HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma

NCT04353375 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2025-12-31

No results posted yet for this study

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.\]

Conditions

  • Advanced Intrahepatic Cholangiocarcinoma
  • Solid Tumor, Adult

Interventions

DRUG

HMPL-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)

Sponsors & Collaborators

  • Hutchmed

    lead INDUSTRY

Principal Investigators

  • Jianming Xu, PhD · Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2028-06-30
Completion
2030-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04353375 on ClinicalTrials.gov