Safety and preliminary efficacy trial of BNT142
Research type
Research Study
Full title
First-in-human, open-label, multicenter, Phase I/IIa, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with CLDN6-positive advanced solid tumors
IRAS ID
1008284
Contact name
Jorge Martinez
Contact email
Sponsor organisation
BioNTech SE
Eudract number
2021-005481-18
Clinicaltrials.gov Identifier
Research summary
This is a two part study investigating the study drug BNT142 as a possible treatment for participants with solid tumours, that express a protein called Claudin-6. BNT142 instructs the immune cells to recognise Claudin-6 on the solid tumour, and potentially destroy the cancer cells. The main purpose of Part 1 is to determine what is the best dosage of the the study drug. The main purpose Part 2 of the study is to further investigate how safe BNT142 is and how well BNT142 works in fighting cancer. Participants in Part 2 of the study will be administered a dosage of BNT142 determined by Part 1 of the study. In both parts of the study, participants will be required to undergo a series of assessments during what is called a screening period, to determine their eligibility to take part. In Part 1 of the study, participants will be be given BNT142 intravenously, in increasing dosages, once every week, in treatment cycles of 21 days. Participants in Part 1, will remain on BNT142 until their cancer worsens, the study doctor decides it is no longer safe for them to continue, or the study ends. In Part 2 of the study, the study drug will be given intravenously once a week in treatment cycles of 21 days. Once treatment is completed, the participants will be followed up long term, every 12 weeks to collect information about their health and any new treatments they are taking. Once treatment is complete, participants in Part 2 will be followed up every 12 weeks for the rest of their life, until the end of the study or until they withdraw their consent.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0910
Date of REC Opinion
15 Nov 2023
REC opinion
Further Information Favourable Opinion