A Phase I Study of IMC-F106C in People with Advanced Solid Tumors Containing Specific Proteins

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Full Title

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

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy drug IMC-F106C that can be given safely in patients with advanced solid tumors containing the immune protein HLA-A*02:01 as well as a protein called PRAME. PRAME is often found in high amounts on cancers such as melanoma, ovarian and uterine cancers, lung cancer, triple-negative breast cancer, and bladder cancer.

IMC-F106C was designed to activate the body’s own immune system to fight cancer. It has two parts: the first part, a T-cell receptor, sticks very tightly to cancer cells that make HLA-A*02:01 and PRAME. The second part, called anti-CD3 scFv, sticks to a T cell. IMC-F106C makes the T cell stick to the cancer cell, and then sends a signal to the T cell to attack the tumor. IMC-F106C is given intravenously (by vein).

Eligibility

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

  • Patients must have tumors that are positive for HLA-A*02:01 and PRAME and came back or continued to grow despite prior treatment. Examples include melanoma, ovarian cancer, endometrial cancer, lung cancer, bladder cancer, and triple-negative breast cancer.
  • Patients should recover from the serious side effects of previous treatments before receiving IMC-F106C.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Hellmann at 646-888-4863.

Protocol

20-305

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators