An open label study of IMCnyeso in patients with advanced cancer
Research type
Research Study
Full title
A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA-A*0201-Restricted, NY-ESO-1 and LAGE-1A specific soluble T Cell Receptor Anti-CD3 Bispecific Molecule as a Single Agent in HLA-A*0201 Positive Patients with Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer
IRAS ID
241824
Contact name
Juanita Lopez
Contact email
Sponsor organisation
Immunocore Ltd
Eudract number
2017-002243-15
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
This research study, sponsored by Immunocore, is looking at a new study medication called IMCnyeso in patients with advanced non-small cell lung cancer (NSCLC), melanoma, urothelial (bladder) cancer or synovial (soft tissue) sarcoma. This study is the first time that the study drug will be given to humans.
The study is made up of two parts. Part 1 (approximately 33 participants) will investigate different doses of IMCnyeso in patients with non-small cell lung cancer (NSCLC), melanoma, urothelial cancer or synovial sarcoma, in order to determine a dose which is safe and effective (recommended phase 2 dose). Part 2 (approximately 30 participants) will further explore the safety and tolerability of IMCnyeso, at the recommended phase 2 dose, in patients with NSCLC, urothelial cancer or synovial sarcoma. Participants will be enrolled in cohorts and dosing decisions will be made by the study safety team. The study will involve approximately 6-10 centres in the US and UK.
IMCnyeso has been developed to treat cancer by activating the body’s own immune system. Participants will be pre-screened for Human Leukocyte Antigen (HLA) type and for specific tumour antigens. Only participants who are HLA- A*0201 positive (about half of the general population) and have tumours expressing NY-ESO-1 and/or LAGE-1A antigens will be eligible for this study.
The study medication will be given as a weekly intravenous infusion in 28 day cycles until the participant experiences disease progression or unacceptable side effects. There is also an option for participants to continue treatment beyond progression, if clinically beneficial for the patient. Study procedures include: medical history, ECG, physical examinations, blood tests, tumour biopsies and CT/MRI scans.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/1252
Date of REC Opinion
4 Oct 2018
REC opinion
Further Information Favourable Opinion