An Open-Label, Single-Arm, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusion/Rearrangement

2019-453-00CH2

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 harboring 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.\]

2020-09-03

2025-06-30

2025-12-31

Recruiting

Early phase I

128

Inclusion Criteria: 1. Signed the informed consent form; 2. Age ≥ 18 years; 3. Patients with histologically or cytologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements; 4. Patients have received at least one prior systemic treatment regimen for advanced intrahepatic cholangiocarcinoma and have intolerable PD or toxicity ; 5. Measurable lesion according to RECIST v1.1, refer to the protocol 6. ECOG performance status of 0 or 1; 7. Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol. Exclusion Criteria: 1. Patients who previously received selective FGFR targeting therapy; 2. Received approved or researched systemic anti-tumor treatment within 3 weeks; 3. Radical radiotherapy within 4 weeks; 4. Have received local anti-tumor treatment within 4 weeks; 5. Major surgery requiring hospitalization or incomplete healing of the surgery incision within 4 weeks; 6. Current or prior history of retinal detachment; 7. Clinically significant cardiovascular disease such as congestive heart failure or arrhythmia; 8. Patients with acute or chronic active hepatitis B or C infection; 9. The patients with human immunodeficiency virus (HIV) infection; 10. Active infection requiring systemic treatment within 1 week; 11. History of significant abnormal calcium phosphorus metabolism; 12. Currently keratopathy confirmed by ophthalmological examination; 13. Toxicities caused by prior anti-tumor treatment have not recovered to grade 0 or 1; 14. Patients who in the opinion of the investigator may be unsuitable for participating in the study; 15. Combined with other malignant tumor or a history of other malignant tumor; 16. Patients currently has central nervous system metastases, meningeal metastases or spinal cord compression.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 128, 'type': 'ESTIMATED'}}

2023-07-06