Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H3 Biomedicine Inc.
• Collaborator: Eisai Inc.

Criteria

Inclusion criteria:

1. 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:

1. 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.