Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
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.
- Advanced Hepatocellular Carcinoma
- Hepatocellular Carcinoma
- Liver Cancer
- Liver Neoplasms
- Hepatic Cancer
- Hepatic Carcinoma
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Participants with hepatocellular carcinoma.
- Must have had at least one prior standard-of-care therapy, unless contraindicated.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- 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).
- Adequate bone marrow and organ function.
- Uncontrolled significant active infections, except hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Known human immunodeficiency virus infection.
- Presence of gastric or esophageal varices requiring active treatment.
- Previous treatment with a selective FGF19-FGFR4 targeted therapy.
- Females of childbearing potential, or males who have not had a successful vasectomy, who are unable or unwilling to follow adequate contraceptive measures.
- Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
- Phase 1
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
H3B-6527 (escalation and expansion)
- H3 Biomedicine Inc.
Study ContactEisai Medical Information