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

Contact:

NCT Number:

Protocol:

AAAU0656

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I/II

This research study mainly aims to test the safety and tolerability of AGEN1181 and balstilimab and to determine the most appropriate dose of the study drug AGEN1181 alone and in combination with balstilimab. AGEN1181 targets cells that are a part of the body’s immune system to block a protein called cytotoxic T- lymphocyte associated protein-4 (CTLA-4). Balstilimab can specially block a protein called programmed-death 1 (PD-1) and prevent communication between this protein and receptors on the tumor-cells. These receptors are known to affect the body’s defense mechanism to identify and fight against cancerous cells. Blocking these proteins is believed to improve the ability of your immune system to fight your cancer. The study drugs are investigational meaning that a regulatory authority, such as the U.S. Food and Drug Administration (“FDA”), has not approved the study drugs for use in people.

Are you Eligible? (Inclusion Criteria)

  • Are you at least 18 years old?
  • Do you have histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no standard therapy is available or standard therapy has failed?
  • You have no history of prior or concomitant malignancy that requires other active treatment

Specialty Area(s)

Sarcomas (Bone and Soft Tissue), Immunotherapy

Principal Investigator

Profile Headshot
  • Associate Director, Experimental Therapeutics
  • Director of Translational Research, Upper Aerodigestive Cancers in Medical Oncology

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032