Extrait

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

Extrait Scientifique

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.;

Critère d'inclusion

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

Critère de non inclusion

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

Liens

• e-cancer.fr
• Fiche de l'U.S. National Library of Medicine (NLM), sur ClinicalTrials.gov