Last updated on January 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Hepatocellular Carcinoma | Cholangiocarcinoma | HEPATOCELLULAR CARCINOMA | Bile duct carcinoma | HEPATIC NEOPLASM | Intrahepatic Cholangiocarcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion criteria:

  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.

Exclusion criteria:

  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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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