Actively Recruiting
HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma
Led by Hutchmed · Updated on 2025-12-31
235
Participants Needed
1
Research Sites
495 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign informed consent
- Age 18 years or older
- Pathologically or cytologically confirmed advanced solid tumor or locally advanced unresectable or metastatic ICC with FGFR2 fusions/rearrangements/mutations
- Have received at least one prior systemic treatment for advanced ICC with progression or intolerance (Cohorts 1-3) or no prior systemic therapy for advanced ICC (Cohort 4)
- Measurable lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Female or male patients with partners of childbearing potential must use effective contraception per protocol
You will not qualify if you...
- Prior treatment with selective FGFR targeting therapy
- Received systemic anti-tumor treatment within 3 weeks before study treatment
- Received radical radiotherapy within 4 weeks
- Received local anti-tumor treatment within 4 weeks
- Major surgery requiring hospitalization or incomplete healing within 4 weeks
- Current or past history of retinal detachment
- Use of strong CYP3A inducers or inhibitors within 2 weeks or 5 half-lives before study treatment
- Use of drugs or supplements affecting blood phosphorus or calcium within 2 weeks before study treatment
- INR above 1.5 or aPTT above 1.5 times upper limit of normal
- Active hepatopathy or moderate to severe liver cirrhosis
- HIV infection
- Active infection requiring systemic treatment within 1 week before study treatment
- Screening blood phosphorus above upper limit or history of abnormal calcium-phosphorus metabolism requiring intervention
- Confirmed keratopathy on eye exam
- Prior or current diseases causing retinal detachment
- Clinically significant arrhythmia or conduction abnormalities requiring intervention
- Known deep vein thrombosis stable for less than 2 weeks
- Unresolved toxicities from prior treatments worse than grade 1
- Conditions affecting drug absorption or inability to take oral medication
- Other or prior malignant tumors within 5 years
- Current central nervous system metastases, meningeal metastases, or spinal cord compression except individual cases
- Other medical conditions or lab abnormalities judged unsuitable by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
B
Bo Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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