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

H3 Biomedicine

Status and phase: Completed; Phase 1

Conditions: Hepatic Cancer; Hepatic Carcinoma; Liver Neoplasms; Hepatocellular Carcinoma; Liver Cancer; Advanced Hepatocellular Carcinoma

Treatments: Drug: H3B-6527

Study type: Interventional

Funder types: Industry

Identifiers

NCT02834780

H3B-6527-G000-101

2016-001915-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

H3B-6527 (escalation and expansion)

Experimental group

Description:

Hepatocellular Carcinoma

Treatment:

Drug: H3B-6527