Woman and Man | Between 18 years et 85 years
- | Country :
- France
- | organs :
- Cerveau
- | Specialty :
- Pharmacologie - Recherche de Transfert
Extract
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
Scientific Abstract
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 (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.
Non-Inclusion Criteria
- 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.