A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

Contact:

NCT Number:

Protocol:

AAAS8402

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I/II

This is a research study to determine how safe and effective a new treatment, called IMC-F106C, is for treating advanced cancers. This study is the first time the study drug is being tested in people. IMC-F106C has been developed to treat cancer by activating the body’s own immune system to fight the tumor. The study drug has 2 parts. The first part, called a “T cell receptor”, sticks very tightly to tumor cells that make markers called “HLA-A*02:01” and “PRAME”. The second part, called “anti-CD3 scFv”, sticks to a T cell (a type of white blood cell that helps protect your body against disease). IMC F106C makes the T cell stick to the cancer cell, which then sends a signal to attack the tumor.

Are you Eligible? (Inclusion Criteria)

  • Are you at least 18 years of age?
  • Are you able to perform every day tasks independently?
  • Have you been diagnosed with melanoma, ovarian carcinoma, uterine carcinoma, NSCLC, SCLC, urothelial carcinoma, or breast cancer?

Specialty Area(s)

Bladder Cancer , Breast Cancer, Gynecologic Cancers, Ovarian Cancer, Uterine (Endometrial) Cancer, Kidney Cancer/Adrenal Cancer, Lung cancer, Skin cancers, Melanoma, Immunotherapy

Principal Investigator

Trial Location(s)

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