Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
Trial Status: Closed to Accrual
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.
- 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.
City of Hope Comprehensive Cancer Center
UCLA / Jonsson Comprehensive Cancer Center
Contact: Lia Etheridge
USC / Norris Comprehensive Cancer Center
Contact: Xiomara Menendez
UC Irvine Health / Chao Family Comprehensive Cancer Center
District of Columbia
MedStar Georgetown University Hospital
Massachusetts General Hospital Cancer Center
Wayne State University / Karmanos Cancer Institute
Dartmouth Hitchcock Medical Center
Hackensack University Medical Center
Duke University Medical Center
University of Pennsylvania / Abramson Cancer Center
Vanderbilt University / Ingram Cancer Center
UT Southwestern / Simmons Cancer Center-Dallas
Contact: Marcella West Aguilar
Trial Phase Phase I
Trial Type Treatment
H3 Biomedicine Inc.
- Primary ID H3B-6527-G000-101
- Secondary IDs NCI-2016-01306, 2016-001915-19
- Clinicaltrials.gov ID NCT02834780