BNT329-01 - Phase I/IIa, FIH, Open Label Study of BNT329 in advanced solid tumors

• Research type

  Research Study

• Full title

  First-in-human, open-label, multi-site, Phase I/IIa, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT329 in participants with advanced solid tumors known to express CA19-9

• IRAS ID

  1012877

• Contact name

  Clinical Trial Information Desk Clinical Trial Information Desk

• Contact email

  patients@biontech.de

• Sponsor organisation

  BioNTech SE

• Clinicaltrials.gov Identifier

  NCT07186842

• Research summary

  The main goal of this clinical study is to learn how safe BNT329 (the study drug) is and how people with advanced or metastatic solid tumours cope with any side effects they may experience and therefore finding the best dose of BNT329.The second goal is to evaluate how well BNT329 works.
  This is the first time that the study drug will be given to people. The study drug is designed to attach to CA19-9, a protein found on the surface of tumour cells. After the study drug is absorbed by the tumour cell, it is designed to cause the death of that tumour cell.
  The study is split into 2 different phases (Phase 1 and Phase 2). Phase 1 will be will be completed first. It will be a dose escalation to investigate the safety and tolerability of BNT329 and be split into 3 parts: Part A, Part B, and Part C (only opened in the future, if considered necessary by researchers).
  Phase 2 (Part D) will be a dose optimization in patients with PDAC.
  Which part participants will be in will depend on when participants join the study.
  Participants will receive the study drug through intravenous (IV) infusion (into the vein) during study centre visits.
  The duration of participation will depend on how the cancer responds to the study drug. Participants will receive BNT329 in cycles for up to 2 years. In Part A, cycles will be 3 weeks long. In Part B, each cycles 4 weeks long. Cycle lengths for Parts C and D will be based on results from Part A and B. This study is “open-label”. This means the study doctor will tell participants which group they are in and which dose of the study drug they will receive. The study is sponsored by BioNTech.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  25/SC/0331

• Date of REC Opinion

  20 Nov 2025

• REC opinion

  Further Information Favourable Opinion