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

a study on Hepatocellular Carcinoma Liver Cancer Hepatic Cancer Hepatic Carcinoma

Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

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.

Official Title

An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma

Keywords

Advanced Hepatocellular Carcinoma Hepatocellular Carcinoma Liver Cancer Liver Neoplasms Hepatic Cancer Hepatic Carcinoma H3B-6527 Fibroblast growth factor receptor 4 (FGFR4) Fibroblast growth factor 19 (FGF19) Carcinoma Carcinoma, Hepatocellular Mitogens H3B-6527 (escalation and expansion)

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • UC Irvine Medical Center accepting new patients
    Orange California 92868-3201 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
H3 Biomedicine Inc.
ID
NCT02834780
Phase
Phase 1
Study Type
Interventional
Last Updated