TCD17465
Research type
Research Study
Full title
A Phase 1/2, Dose Escalation, Dose Expansion, and Dose Optimization Study of the Safety, Tolerability, and Anti-tumor Activity of SAR444881 Administered Alone and in Combination With Pembrolizumab, Cetuximab and/or chemotherapy in Participants With Advanced Solid Tumors
IRAS ID
1008885
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-504937-30
Clinicaltrials.gov Identifier
Research summary
The main purpose of this study is to find out about the safety and tolerability of SAR444881 alone and in combination with pembrolizumab or cetuximab for the treatment of advanced solid tumors. Another purpose of this study is to look for initial signs of effectiveness of SAR444881 for the treatment of advanced solid tumors.
This study is an open-label, sequential dose-escalation, dose-expansion, and dose-optimization, multi-arm study where each person participates for up to 2 years. Open-label means that the participants and researchers both know which treatment is given.
In this protocol, the investigational medicinal products are SAR444881, pembrolizumab, cetuximab, carboplatin, and pemetrexed. Other medicines included in the study are diphenhydramine, folic acid, vitamin B12, and dexamethasone.
SAR444881 is a monoclonal antibody (a type of protein produced by your body’s immune system) that attaches to immune cells and helps the immune system target and attack cancer cells. Researchers believe that SAR444881 may be able to help decrease the growth of cancer cells.
Participants will be assigned to a treatment arm/dose level in the order of study entry.
Inclusion criteria include adults with confirmed advanced and/or metastatic solid tumors whilst people with certain medical problems, or anything else that makes them unsuitable for the study, will not be able to take part.
The benefits and risks of SAR444881 are not known at this time. However, the study design aims to minimize potential risks and the study medicine is being tested as it has the potential to provide clinical benefits (ie, antitumor activity) in participants with metastatic and/or advanced solid tumors.REC name
West of Scotland REC 1
REC reference
23/WS/0173
Date of REC Opinion
22 Feb 2024
REC opinion
Further Information Favourable Opinion