BNT323-03
Research type
Research Study
Full title
A Phase I/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, and pharmacokinetics of BNT323 in combination with BNT327 in participants with advanced breast cancer
IRAS ID
1011776
Contact name
Jack Churchill
Contact email
Sponsor organisation
BioNTech SE
Clinicaltrials.gov Identifier
Research summary
There is an unmet need for therapies to treat patients who have cancers with low or very low levels of human epidermal growth factor receptor 2 (HER2) as therapies are often ineffective and have significant side effects. This study tests the safety and tolerability of investigational study drugs, BNT323 and BNT327, and if these stop certain breast cancers from worsening.
The study is divided into two parts:
Part 1-finds the best dose of the combination of the two study drugs. Starting with low doses, various combinations will be tested for safety and effectiveness.
Part 2 will consist of 4 cohorts:
- cohort 1 will look at optimising the dose of study drugs established during part 1 and will consist of 4 arms. Arm 1 will use the recommended dose from part 1; arm 2 will look at a lower than recommended dose; arm 3 will look at BNT323 only; and arm 4 will look at BNT327 only. If there are tolerance issues in arms 3 and 4, participants may be able to either switch to the other study drug or have the other study drug added during their monotherapy treatment.
- cohorts 2, 3 and 4 will explore the effectiveness of the recommended dose of study drugs from part 1 on specific tumour types.Up to 380 participants are planned to be enrolled (60 in part 1, 320 in part 2). Potential participants will undergo screening tests (28 days) to confirm that they are eligible. For each participant, the treatment will last approximately 8 months (up to max 36 months) after which participants will enter a 3-month long safety follow up period to monitor any side effects, followed by a long term follow up period until withdrawal of consent, study closure, loss to follow-up or death, whichever occurs first.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0112
Date of REC Opinion
13 Jun 2025
REC opinion
Further Information Favourable Opinion