BNT326-02

• Research type

  Research Study

• Full title

  A Phase Ib/II, multi-site, open-label, dose finding trial to evaluate the safety, efficacy, and pharmacokinetics of BNT326 in combination with BNT327 in participants with advanced non-small cell lung cancer (NSCLC).

• IRAS ID

  1011576

• Contact name

  Clinical Trial Information Desk Clinical Trial Information Desk

• Contact email

  patients@biontech.de

• Sponsor organisation

  BioNTech SE

• Research summary

  This is a phase Ib/II open-label, two-part trial to look how safe and well tolerated the study drug (called BNT326) is when given in combination with drug BNT327 and whether it helps to prevent cancer from getting worse in participants with advanced non-small cell lung cancer (NSCLC). This study is divided into three separate parts:
  • Part 1: This is the dose escalation phase which will evaluate the safety, how well BNT326 is tolerated, and its anticancer activity when given in combination with BNT327. There will be 3 dose levels of BNT326.
  • Part 2a: Part 2a has two cohorts (called Cohort A and Cohort B). All cohorts will evaluate the safety, how well BNT326 is tolerated, and the anti-cancer activity of BNT326 when given in combination with BNT327. There will be 2 dose levels of BNT326 in each cohort. Cohorts differ with regards to participant’s prior anti-cancer treatment.
  • Part 2b: Part 2b has two cohorts (called Cohort C and Cohort D), with several treatment arms. Cohort C will compare the safety and the anti-cancer activity of BNT326 when given in combination with BNT327 and BNT326 on its own (monotherapy).
  Cohort D will compare the compare the safety and the anti-cancer activity of BNT326 when given in combination with BNT327, BNT327 on its own (monotherapy), the standard of care treatment pembrolizumab and chemotherapy.

  In total, up to 420 participants are planned to be enrolled (up to 60 participants in Part 1, 160 participants in Part 2a and up to 200 participants in Part 2b).
  For each trial participant, the treatment and follow-up periods are projected to be completed within: 24 months if receiving BNT326 in combination with BNT327, BNT326 monotherapy or BNT327 monotherapy, or until disease progression, withdrawal of consent, termination of the trial by the sponsor, unacceptable toxicity, or, if applicable, for the maximum duration as guided per local product label, if receiving SoC.

  This study is sponsored by BioNTech SE.

• REC name

  Wales REC 2

• REC reference

  25/WA/0201

• Date of REC Opinion

  15 Sep 2025

• REC opinion

  Further Information Favourable Opinion