Phase II Study of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma With FGFR2 Fusion

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, single arm, multicenter and open-label study to evaluate the efficacy, safety and pharmacokinetic of HMPL-453 tartrate in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited

Criteria

Inclusion Criteria:

1. Signed written informed consent;

2. 18 years of age or older;

3. Histologically diagnosed as intrahepatic cholangiocarcinoma with FGFR2 fusion, and cannot be cured radically;

4. Received at least one regimen of prior systemic therapy and then experienced documented radiographic progression or intolerable toxicity;

5. Measurable disease by RECIST version 1.1 criteria;

6. ECOG performance status ≤ 1.

Exclusion Criteria:

1. Previous treatment with selected FGFR2 inhibitors;

2. Received systemic anti-cancer therapy within 2 weeks of the first dose of HMPL-453;

3. Major surgery within 4 weeks of the first dose of HMPL-453;

4. Use of a strong inducer or inhibitor of cytochrome P450 3A4 (CYP3A4) within 1 week of the first dose of HMPL-453;

5. Inadequate liver or kidney insufficiency;

6. Clinical significant liver diseases;

7. Known human immunodeficiency virus (HIV) infection;

8. Previous history of retinal detachment;

9. Unable to swallow the study drug.