Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
Purpose
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
Conditions
- Advanced Hepatocellular Carcinoma
- Hepatocellular Carcinoma
- Liver Cancer
- Liver Neoplasms
- Hepatic Cancer
- Hepatic Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants with hepatocellular carcinoma. 2. Must have had at least one prior standard-of-care therapy, unless contraindicated. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Must be willing to undergo a biopsy up to 8 weeks before administration of H3B-6527 on Cycle 1 Day 1 for part 2 (dose expansion). 5. Adequate bone marrow and organ function.
Exclusion Criteria
- Uncontrolled significant active infections, except hepatitis B virus (HBV) or hepatitis C virus (HCV). 2. Known human immunodeficiency virus infection. 3. Presence of gastric or esophageal varices requiring active treatment. 4. Previous treatment with a selective FGF19-FGFR4 targeted therapy. 5. Females of childbearing potential, or males who have not had a successful vasectomy, who are unable or unwilling to follow adequate contraceptive measures. 6. Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental H3B-6527 (escalation and expansion) |
Hepatocellular Carcinoma |
|
More Details
- Status
- Completed
- Sponsor
- H3 Biomedicine Inc.