Study of IMC-C103C as monotherapy and in combination with Atezolizumab
Research type
Research Study
Full title
A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-C103C as a Single Agent and in Combination with Atezolizumab in HLA-A*0201-positive Patients with Advanced MAGE-A4-positive Cancer
IRAS ID
261616
Contact name
Nicola McKelvie
Contact email
Sponsor organisation
Immunocore Limited
Eudract number
2018-003120-36
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
137,164, IND Number
Duration of Study in the UK
3 years, 6 months, 8 days
Research summary
The study drug IMC-C103C is an experimental drug developed to help the body’s own immune system to fight tumours. This is a first in man study which has two parts. The goal of the first part is to find the highest dose of IMC-C103C alone or in combination with atezolizumab that can be given to patients with advanced cancers, without too many side effects. The goal of the second part is to learn if this dose can help control advanced cancers. Participants will be assigned to receive a specific dose of IMC-C103C alone or in combination with atezolizumab. The assignment will depend on when the participant joins the study. Neither the participant nor the study doctor may choose the dosing group.
Approximately 174 patients from 3 countries will participate in this research study. Participants will need to spend the night in the hospital after the first 2-3 doses of IMC-C103C and attend clinic visits every week for study dosing (by infusion into a vein) and blood tests to check their health. On some visits participants will have scans to check if their tumours are growing. Participants will receive IMC-C103C until their cancer gets worse or they have a severe side effect. There is a safety visit 1 month after the last dose of study drug. If the participant stops study treatment but their cancer has not gotten worse, they may be asked to visit the study site every 2-3 months to check on the status of their disease, until it gets worse. After this, participants will receive a follow-up phone call from the study site every 3 months until the end of the study.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/1792
Date of REC Opinion
3 Jan 2020
REC opinion
Further Information Favourable Opinion