EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial – 1)
Research type
Research Study
Full title
A Modular, Multi-part, Multi-arm, Open-label, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD5769 Alone and in Combination with Anticancer Treatments in Patients with Solid Malignancies.
IRAS ID
1007712
Contact name
Dr Peter Joyce
Contact email
Sponsor organisation
Grey Wolf Therapeutics
Research summary
This is a modular, Phase I/II, open-label, study to investigate GRWD5769 alone, and in combination with cemiplimab 350 mg.
The main purpose of the study is to determine if the study drug GRWD5769 is safe and well tolerated, and to measure the amount of drug in participants blood to work out what doses are likely to work best.
GRWD5769 works by stopping an enzyme in the body, called endoplasmic reticulum aminopeptidase 1 (ERAP1), from working. ERAP1 is part of how the body recognizes that person has a cancer tumour and helps trigger the immune system to fight the cancer. However, the immune system cells can become exhausted and no longer work effectively. By blocking ERPA1 it makes the tumour look different to the person's immune system and the immune system starts fighting the cancer again. Studies have been conducted in animals which support the use of GRWD5769 in humans for the treatment of advanced solid tumours in a broad range of cancer types.
Grey Wolf Therapeutics Ltd (the study Sponsor) is developing GRWD5769 as a potential new treatment for advanced or metastatic solid malignancies. GRWD5769 is an experimental treatment, which means that it is not an approved treatment for advanced or metastatic cancers in the United Kingdom (UK) or anywhere else in the world. This is the first time that GRWD5769 will be given to humans.This study consists of Module 1 (Parts A to D), which will look at the effects of GRWD5769 when given alone and Module 2 (Parts A to C) which will look at the effects of GRWD5769 when given in combination with another anticancer drug called Libtayo® (cemiplimab).
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0547
Date of REC Opinion
16 Oct 2023
REC opinion
Further Information Favourable Opinion