Protocol
12-145
Full Title
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients with Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Purpose
Inoperable advanced liver cancer that returns or persists despite prior therapy is challenging to treat successfully. In this study, researchers are evaluating the safety and effectiveness of an investigational drug called GC33 in patients with previously treated advanced or metastatic hepatocellular carcinoma that cannot be surgically removed.
GC33 is an antibody that targets a protein called GPC3 and triggers an immune response against GPC3-expressing cancer cells, which may result in cancer cell death. GPC3 is produced at high levels in hepatocellular carcinoma. Patients in this study will be randomly assigned to receive GC33 or a placebo.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have advanced or metastatic liver cancer that persists despite at least one prior regimen of systemic therapy and cannot be surgically removed.
- Patients’ tumors need to express a certain level of GPC3.
- All previous treatments must have been completed at least 2 weeks before entering the study, and patients must have recovered from any serious side effects.
- 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
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