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

Completed · Phase 1

Conditions studied: Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms, Hepatic Cancer, Hepatic Carcinoma

In brief

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.

Key facts

Study ID

NCT02834780

Run by

H3 Biomedicine Inc.

People needed

128

Starts

2016-12-28

Expected to finish

2022-02-23

Last updated by the study team

2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• UC Irvine Medical Center — Orange, California, United States
• UCLA Medical Center — Santa Monica, California, United States
• Georgetown Unversity Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• Northwestern Unversity — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• John theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Duke University Cancer Center — Durham, North Carolina, United States
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
• University of Pennsylsvania - Perelman Cancer Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• Simmons Comprehensive Cancer Center — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• McGuire VA Medical Center — Richmond, Virginia, United States
• UCL Cliniques universitaires Saint-Luc — Woluwe-Saint-Lambert, Brussels Capital, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Jurvanski Cancer Center — Hamilton, Ontario, Canada
• Institut Bergonié — Bordeaux, France
• Centre Oscar Lambret — Lille, France
• Hôpital Haut-Lévêque - CHU de Bordeaux — Pessac, France
• Centre Eugène Marquis — Rennes, France
• IRCCS Istituto Scientifico Romagnolo per lo studio e la cura dei tumori - U.O. di Oncologia Medica — Meldola, Italy
• IRCCS Ospedale San Raffaele S.r.l. - PPDS — Milan, Italy

Full record on ClinicalTrials.gov

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