A Phase I Study of GC33 plus Sorafenib in Patients with Advanced Hepatocellular Carcinoma

Protocol
10-021
Full Title
A Phase I, Open-Label, Multi-Center, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 in Combination with Sorafenib (Nexavar) in Patients with Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Purpose

The purpose of this study is to determine the optimal dose and assess the safety and effectiveness of combining an investigational drug called GC33 with sorafenib in patients with advanced hepatocellular carcinoma (liver cancer). GC33 is a type of drug called a monoclonal antibody. It binds to the glypican-3 (GPC3) protein, which is found on many liver tumor cells. GC33 also binds to very powerful cells of the immune system called natural killer cells. GC33 causes the tumor to die by bringing the tumor cells in contact with natural killer cells.

Sorafenib (Nexavar®) is already approved for the treatment of liver cancer. It works by stopping a signal made by cancer cells that they need to multiply and grow, and through inhibiting blood supply to cancer cells. Sorafenib is a capsule that is taken by mouth.

Investigator
Ghassan K. Abou-Alfa, MD
Ghassan K. Abou-Alfa - Physician Profile
Co-Investigators
Jorge A. Carrasquillo, MD
Jorge A. Carrasquillo - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of hepatocellular carcinoma that has spread or is not responding to standard therapies.
  • At least 4 weeks must have passed since the completion of prior therapies and entry into the study.
  • Patients who have already taken sorafenib may not participate.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.

Disease(s)
Hepatobiliary: Liver Cancer
Locations
ClinicalTrials.gov
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