BNT314 (DuoBody®-EpCAMx4-1BB)
Research type
Research Study
Full title
A first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate the safety and preliminary efficacy of BNT314 in monotherapy and in combination with an immune checkpoint inhibitor in patients with advanced malignant solid tumors
IRAS ID
1008686
Contact name
Clinical Trial Information Desk Clinical Trial Information Desk
Contact email
Sponsor organisation
BioNTech SE
Research summary
The purpose of this study is to assess the safety and to establish a safe and effective dose of the study drug called BNT314 and get information about how well it works for a type of cancer called a solid Tumour which can be found in different parts of the body. This study is sponsored by BioNTech. Around 360 research participants globally, will take part in the study. The Trial will be conducted in 2 parts (Dose escalation & Dose expansion)
Dose escalation - The main aim of the dose escalation part is to test different doses of the study drug. Dose expansion part - The dose expansion part of the study will start only after safety data from the dose escalation part has been reviewed. Based on that information, 2 doses of the study drug will be selected to be tested in the dose expansion part.
The dose escalation and dose expansion parts consist of 5 periods: Screening (up to 28 days), Treatment (duration depends on how the cancer responds to the study treatment), End of treatment visit, Safety follow-up (about 90 days) and Long-term follow-up (at least 12 months).
Eligible participants will receive either the study drug alone or with pembrolizumab. Both of these are called the “study treatment” and they are given as intravenous (IV) infusion every 3 weeks (21 days).
This study will look at:
• side effects from the study drug
• how the body processes the study drug (pharmacokinetics)
• how the body reacts to the study drug (immunogenicity)
• if the study drug targets the cancer (pharmacodynamic biomarker evaluation)
• whether the study drug works against the type of cancer participants have in the trial.
The study will also look at how safe the study drug is and whether it works when given in combination with another anticancer medication.
BNT314 is an Investigational Medicinal Product that is being tested in this study. Investigational means that the study drug has not yet been approved for the treatment of advanced solid tumours by health authorities.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
24/EE/0008
Date of REC Opinion
12 Feb 2024
REC opinion
Further Information Favourable Opinion