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

Status:	Recruiting
Conditions:	Liver Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/4/2019
Start Date:	July 2016
End Date:	June 2020
Contact:	Eisai Medical Information
Email:	esi_oncmedinfo@eisai.com
Phone:	1-888-274-2378

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

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:

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.

Exclusion criteria:

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.

We found this trial at

sites

John Theurer Cancer Center at the Hackensack University Medical Center

92 2nd St
Hackensack, New Jersey 07601

(201) 996-5900