A study to investigate the safety of BNT324 and BNT327 in advanced lung cancer patients (BNT324-01)
Research type
Research Study
Full title
A Phase Ib/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, pharmacokinetics, and recommended combination dose of BNT324 with BNT327 in participants with advanced lung cancer
IRAS ID
1011622
Contact name
Karisha Browne
Contact email
Sponsor organisation
BioNTech SE
Clinicaltrials.gov Identifier
Research summary
This is a phase Ib/II open-label, two part trial to assess the safety and to establish a safe and effective dose of BNT324 in combination with BNT327 to help control advanced or metastatic lung cancer. BNT324, is designed to target a protein called B7-H3, which is found in large amounts in many cancer cells. BNT324 aims to deliver targeted chemotherapy to these cancer cells and may help slow down or stop the growth. The other study drug, called BNT327, is designed to block the proteins PD-L1 and VEGF-A, which play a role in tumour growth and forming blood vessels that can feed cancer cells. BNT327 may help reduce tumour growth and improve the effectiveness of cancer treatment. It is thought that both drugs given in the same visit may further improve to reduce the growth of cancer cells.
The study consists of a screening period (up to 28 days), a study treatment period consisting of 21-day (3-week) cycles, for a maximum of 24 months for BNT324 and 36 months for BNT327, a safety follow-up period lasting about 90 days (3 months) to monitor any possible late side effects of the study drugs and a long-term follow-up period of up to 4 years (48 months).
The study has 2 parts but participants will only join one part of the study based on the study design and their eligibility.
Part 1: This part will assess different doses (called dose levels) of the study drugs, BNT324 and BNT327, to find the best combination dose. This is known as dose finding.
Part 2: This part will further investigate the safety and effectiveness of one or two safe and tolerable doses identified in Part 1. This part includes:
• Dose optimisation groups will help researchers select the most appropriate dose of the study drugs.
• Signal-seeking groups are groups of participants that help researchers gather early information about the effects of the study drugs.
In total, up to 594 participants are planned to be enrolled (up to 274 participants in Part 1 and up to 320 participants in Part 2.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
25/YH/0070
Date of REC Opinion
3 Jun 2025
REC opinion
Further Information Favourable Opinion