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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: 15 Aug 2025

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At a glance

  • Drugs BNT 323 (Primary) ; PM-8002 (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

  • 11 Jul 2025 Number of treatment arms increased from 7 to 8 by the addition of "Experimental: Part 2 Cohort 4 - Selected dose level of BNT323 + BNT327" arm.
  • 11 Jul 2025 Planned number of patients changed from 320 to 380.
  • 11 Jul 2025 Planned End Date changed from 1 Sep 2032 to 1 May 2029.

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