A Phase I Study of AGEN1811 and Balstilimab Immunotherapy in People with Fibrolamellar Carcinoma or Another Type of Gastrointestinal Cancer

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Full Title

A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034 (balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer

Purpose

The purpose of this study is to assess the safety of giving combination treatment with the investigational drug AGEN1811 and another medication called balstilimab in people with advanced fibrolamellar carcinoma (FLC) or another type of advanced digestive cancer that has come back or continued to grow despite therapy. Both drugs work by blocking proteins that cancer cells use to avoid being seen by the immune system. They boost the ability of the immune system to find and kill cancer cells. AGEN1811 and balstilimab are each given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have advanced FLC or another digestive cancer (microsatellite stable colorectal cancer, pancreatic cancer, biliary cancer, gastric cancer, or ampullary cancer) that came back or continued to grow despite prior treatment.
  • At least 3 weeks must pass between the completion of previous treatments and receipt of the study therapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

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

Protocol

22-069

Phase

I

Investigator

Co-Investigators