Unknown Cancer NIHR-supported project Lungs & Breathing

BNT324-01 - A Phase Ib/II, multi-site, open-label,two part trial to evaluate the efficacy,safety, pharmakokinetics,and recommended combination dose of BNT324 with BNT327 in advanced lung cancer

Funder NIHR (part of DHSC)
Recipient organisation NIHR Wellcome Trust UCL Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Ongoing

In plain English

AI plain-English summary

A new clinical trial is testing whether pairing a targeted chemotherapy drug with a dual-action immunotherapy can shrink advanced lung tumours that have resisted previous treatments. This matters because advanced lung cancer remains difficult to control once it has spread. Many tumours grow aggressively, partly because they produce large amounts of a protein called B7-H3 on their surface, and because they use PD-L1 and VEGF-A to suppress the immune system and build blood vessels that feed the cancer. Current treatments often stop working over time. The trial combines BNT324, which delivers chemotherapy directly to B7-H3-positive cancer cells, with BNT327, which blocks both PD-L1 and VEGF-A simultaneously. The idea is that hitting the tumour from multiple angles in a single visit may slow or stop growth more effectively than either drug alone. If the combination proves safe and effective, it could offer a new treatment option for patients with advanced lung cancer who have few alternatives. The trial is structured in two parts: an initial dose-finding phase, followed by a larger expansion phase to confirm efficacy.

View original technical description
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). 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.

Researchers

Martin Forster (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

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
A Phase II/III, multisite, randomized master protocol for a global trial of BNT327in combination with chemotherapy and other investigational agents in first-linenon-small cell lung cancer
A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with cancer immunotherapies in participants with advanced solid tumors.
BNT326-01: A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with cancer immunotherapies in participants with advanced solid tumors
A Phase II, multi-site, open-label, parallel group trial of BNT327 in combination with chemotherapy for participants with untreated extensive-stage small-cell lung cancer and participants with previously treated small-cell lung cancer (BNT327)

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