Phase I/II trial of BNT314+BNT327 with chemotherapy in Metastatic Colorectal Cancer
Research type
Research Study
Full title
A Phase I/II, randomized, multi-site trial to investigate the efficacy and safety of BNT314 in combination with BNT327 and chemotherapy in participants with metastatic colorectal cancer
IRAS ID
1012259
Contact name
Esha Dasgupta
Contact email
Sponsor organisation
BioNTech SE
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to assess the safety and to establish a safe and effective dose of a combination of the Investigational Medicinal Product or study drugs called BNT314 and BNT327 and get information about how well it works for metastatic colorectal cancer. BNT314 and BNT327 are currently being tested in humans. The study is split into 3 different parts (parts A, B, and C). Part A of the study aims to:
• see how safe the combination of study drugs are
• find out whether participants can cope with any side effects the study drugs may cause (called “tolerability”)
• find the safe and effective dose of the study drugs to use in future parts of the study (Part B and C). The “safe and effective dose” of the study drugs is a specific combination of study drugs that offers the best balance between providing potential medical benefit and minimizing potential side effects for the patient
• check whether the study drugs work by stopping disease progression or reducing the tumour size
• see how your body processes the study drugs (known as pharmacokinetics, or PK)
• understand how your immune system responds to the study drugs (known as immunogenicity).
There are 4 periods in this study. We expect that taking part in this study will depend on how the cancer responds to the study drugs. The participant will receive the study drugs for up to 2 years.
• Screening period (about a month)
• Study treatment period (up to 2 year)
• Safety follow-up period (about 3 months)
• Long-term follow-up period
This study is a Phase 1 study. Phase 1 studies are usually the earliest studies of potential new drugs in people. They are usually small studies, recruiting only a few participants. Phase 1 studies assess the safety of a study drug.REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0224
Date of REC Opinion
14 Aug 2025
REC opinion
Further Information Favourable Opinion