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

a study on Hepatocellular CarcinomaLiver CancerCholangiocarcinomaHepatic CancerHepatic 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 or Intrahepatic Cholangiocarcinoma

Keywords

Advanced Hepatocellular CarcinomaIntrahepatic CholangiocarcinomaHepatocellular CarcinomaLiver CancerLiver NeoplasmsHepatic CancerHepatic CarcinomaCholangiocarcinomaBile Duct CancerH3B-6527FGFR4FGF19CarcinomaCarcinoma, HepatocellularBile Duct NeoplasmsH3B-6527 (escalation and expansion)

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Participants with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).
  2. Must have received at least one prior standard-of-care therapy or declined such therapy.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  4. Must be willing to undergo a biopsy prior to treatment and on Cycle 2 Day 1 (Part 2 only).
  5. Adequate bone marrow and organ function.

You CAN'T join if...

  1. Uncontrolled significant active infections, except Hepatitis B (HBV) or Hepatitis C (HCV).
  2. Known human immunodeficiency virus (HIV) infection.
  3. Presence of gastric or esophageal varices requiring active treatment.
  4. Previous treatment with 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.

Locations

  • UC Irvine Medical Centeraccepting new patients
    OrangeCalifornia92868-3201United States
  • UCLA Medical Centeraccepting new patients
    Santa MonicaCalifornia90404United 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