Phase 2 Study of HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma

Launched by HUTCHMED · Apr 16, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HMPL-453 tartrate for patients with advanced intrahepatic cholangiocarcinoma, which is a type of cancer that starts in the liver. The main focus of the trial is to see how well this treatment works for patients who have a specific genetic change (called FGFR2 fusion/rearrangement) and have already tried at least one other treatment that didn’t work or caused side effects they couldn’t tolerate. Participants will take HMPL-453 tartrate by mouth daily for two weeks, followed by a week off, repeated in cycles.

To be eligible for this trial, patients must be at least 18 years old, have confirmed advanced cancer that cannot be surgically removed, and have experienced treatment failure or side effects from previous therapies. Patients who have received certain prior treatments or have specific health conditions may not be able to participate. If eligible, participants will have regular check-ins to monitor their health and response to the treatment. This trial is currently recruiting, and it aims to provide new insights into treatment options for patients facing this challenging cancer.

Gender

ALL

Eligibility criteria

• 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.