Status:
RECRUITING
HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Hutchmed
Conditions:
Advanced Intrahepatic Cholangiocarcinoma
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 th...
Detailed Description
This is an open-label, single-arm, multicenter phase 2/3b clinical study to evaluate the efficacy and safety of HMPL-453 tartrate in the treatment of patients with advanced ICC habouring FGFR2 fusions...
Eligibility Criteria
Inclusion
- 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)
- Measurable lesion according to RECIST v1.1;
- ECOG performance status of 0 or 1;
- Life expectancy ≥ 12 weeks;
- Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol.
Exclusion
- 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;
- Major surgery requiring hospitalization or incomplete healing of the surgery incision within 4 weeks;
- Current or prior history of retinal detachment;
- Using a strong inducer or inhibitor of cytochrome P450 3A (CYP3A) within 2 weeks or 5 half-lives of the study treatment;
- Taking drugs or dietary supplementsthat may cause blood phosphorus and/or blood calcium to rise within 2 weeks prior to the start of the study treatment;
- International normalized ratio above 1.5 or partial activated prothrombin time above 1.5 times ULN;
- History of clinically significant active hepatopathy, including active viral hepatitis, or other active hepatitis, clinically significant moderate to severe liver cirrhosis;
- The patients with human immunodeficiency virus (HIV) infection;
- Active infection requiring systemic treatment within 1 week prior to the start of the study treatment;
- Screening blood phosphorus levels above ULN, or history of abnormal calcium phosphorus metabolism requiring clinical intervention or relevant medical history;
- Currently keratopathy confirmed by ophthalmological examination;
- Prior history of retinal detachment, or current diseases that may cause retinal detachment;
- Clinically significant arrhythmia or conduction abnormalities requiring clinical intervention;
- Patients with known deep venous thrombosis, treated with low molecular weight heparin (LMWH) or drugs with similar efficacy, and the investigator judges that the thrombosis is stable for ≥ 2 weeks ;
- Toxicities caused by prior anti-tumor treatment have not recovered to grade 0 or 1;
- The patient has any current disease or condition that affects drug absorption, or the patient cannot be orally administered;
- Combined with other malignant tumor or a history of other malignant tumor within 5 years prior to study screening;
- Patients currently has central nervous system metastases, meningeal metastases or spinal cord compression, except in individual cases;
- Any other medical condition or clinically significant laboratory abnormalities judged by the investigator would make the patients unsuitable to participate in this study.
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2030
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT04353375
Start Date
September 3 2020
End Date
February 28 2030
Last Update
December 31 2025
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China