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

Research summary

This research study sponsored by Immunocore is looking at a new medication called IMC-F106C (study drug) in patients with advanced cancer, and is the first time the study drug will be given to humans. This study will identify the maximum dose of study drug which is safe and the dose recommended for any further studies of the drug. The study will provide a preliminary assessment of antitumor efficacy of IMC-F106C as monotherapy (single treatment) and in combination with an immunotherapy drug. IMC-F106C is designed to activate the body’s immune system to fight tumours. Arm A (approximately 34 participants) will test different doses of IMC-F106C to find a dose which is safe and well tolerated. Arm B (approximately 26 participants) will examine safety and tolerability of IMCF106C along with the immunotherapy drugs atezolizumab (Arm B-1) and pembrolizumab (Arm B-2). Participants will be tested for Human Leukocyte Antigen (HLA) type (personal immune system type) and for specific tumour antigens (markers on cancer cells). Only participants who are HLA- A*0201 positive (about half of the general population) and have a PRAME (preferentially expressed antigen in melanoma) positive tumour can join the study. IMC-F106C has 2 parts. The first part, “T cell receptor”, sticks to tumour cells that make markers “HLA-A*02:01” and “PRAME”. The second part, “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, and send a signal to attack the tumour. IMC-F106C is given weekly via a fine needle into a vein, until the cancer is no longer controlled by the study drug or there are unwanted or unacceptable side effects. Study procedures include: medical history, ECG, physical examinations, blood tests, tumour biopsies and CT/MRI scans.

Principal Investigator

Prof Mark Middleton

Contact us

Email: orh-tr.earlyphasenurses@nhs.net

IRAS number

275567