First-in-human BNT411-01 dose-escalation with expansion cohorts
Research type
Research Study
Full title
Phase 1/2a, first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT411 as a monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).
IRAS ID
274939
Contact name
Stefan Symeonides
Contact email
Sponsor organisation
BioNTech SE
Eudract number
2019-003593-17
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
144377, IND; 20/NW/0073, REC Reference
Duration of Study in the UK
3 years, 6 months, 29 days
Research summary
Study BNT411-01 is an open-label, multicentre, dose-escalation, safety, pharmacokinetic (PK) and pharmacodynamics (PD) trial of BNT411 with expansion cohorts in a mixed population of patients with solid tumors.
The trial consists of three parts:
• Part 1A will be a monotherapy dose escalation in patients with advanced solid cancers until the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BNT411 as monotherapy are defined.
• Part 1B will be a combination dose escalation in patients with chemotherapy-naïve ES-SCLC until the MTD and/or RP2D of BNT411 in combination with atezolizumab, carboplatin and etoposide are defined.
• Part 2 will consist of expansion cohorts in solid cancers based on data generated in Part 1A and Part 1B. A “backfilling” approach will be implemented where more patients will be enrolled in selected dose levels in both Part 1A and Part 1B to explore further safety and anti-tumor activity.
Between 6 to 33 patients are planned to be enrolled in Part 1A and between 6 to 30 patients are planned to be enrolled in Part 1B.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0073
Date of REC Opinion
9 Apr 2020
REC opinion
Favourable Opinion