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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.

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Lia Etheridge
Phone: 310-825-7174
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Xiomara Menendez
Phone: 323-717-7708
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: IN_REVIEW

New Jersey

Hackensack
Hackensack University Medical Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Marcella West Aguilar
Phone: 214-648-1479

Trial Phase Phase I

Trial Type Treatment

Lead Organization
H3 Biomedicine Inc.

  • Primary ID H3B-6527-G000-101
  • Secondary IDs NCI-2016-01306, 2016-001915-19
  • Clinicaltrials.gov ID NCT02834780