BNT151 as a monotherapy and in combination in patients with tumours
Research type
Research Study
Full title
Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT151 as a monotherapy and in combination with other anti-cancer agents in patients with solid tumors
IRAS ID
288008
Contact name
Anja Williams
Contact email
Sponsor organisation
BioNTech SE
Eudract number
2019-003572-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, days
Research summary
Research Summary:
The purpose of the study is to assess the safety and establish a safe and effective dose of taking BNT151 (study drug) when given alone (which is called monotherapy)and in combination to get information about how it works in the body(pharmacodynamics/PD in participants with cancer.
BNT151 will be tested in humans for the first time. This study will also measure the amount of BNT151 in the blood at various time-points (pharmacokinetics/PK).
In part 1, up to 54 plus 10 additional patients will take part in the study. In Part 2, 6-12 patients per cohort will take part in the study, so 30-60 patients in 8 research sites in North America and Europe will take part in this trial.
The trial consists of Part 1, Part 2A and Part 2B with adaptive design elements.
The Part 1, monotherapy part of the trial will be preceded by an enrollment and screening period of 13 months. Participants are screened at a Screening Visit up to 21 days (3 weeks) prior to beginning of treatment.
Following discontinuation, and a safety follow up period of 60 days, patients will be followed up for survival every 12 weeks until death.Part 2 consist of part 2a and 2b. In part 2a patients with squamous cell carcinoma of head and neck (SCCHN), and hepatocellular carcinoma (HCC) will be enroled and treated with a combination of BNT151 and pembrolizumab. Once Part 2A of SCCHN and HCC is completed, patients with RCC, non-small cell lung cancer (NSCLC), and triple negative breast cancer (TNBC) will be enrolled and treated with a combination of BNT151 with the respective SoC. information about the combination treatments will be submitted by amendment.
Lay summary of study results:
BNT151-01 was never initiated in the UK and no sites were activated on the study. No UK subjects were recruited in this study and therefore no Lay Synopsis for UK subjects will be published.REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/1273
Date of REC Opinion
5 Mar 2021
REC opinion
Further Information Favourable Opinion