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

Barbara Ann Karmanos Cancer Institute

4100 John R
Detroit, Michigan 48201

800-527-6266

Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...

from

Detroit, MI