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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Sep 2026

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At a glance

  • Drugs BNT 323 (Primary) ; Pumitamig (Primary)
  • Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors BioNTech

Most Recent Events

  • 23 Jun 2026 Planned End Date changed from 1 May 2029 to 1 Aug 2029.
  • 23 Jun 2026 Planned primary completion date changed from 1 May 2028 to 1 Aug 2029.
  • 24 Mar 2026 According to Duality Biotherapeutics media release, data from this trial expected to be available in 2026.

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