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A Phase I/II, First-in-human, Open-label, Dose Escalation and Indication Expansion Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

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Trial Profile

A Phase I/II, First-in-human, Open-label, Dose Escalation and Indication Expansion Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Jun 2026

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At a glance

  • Drugs BNT 3212 (Primary) ; Pumitamig (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors BioNTech

Most Recent Events

  • 06 Apr 2026 New Efficacy Primary endpoint has been added and hence the overall trial focus has changed.
  • 06 Apr 2026 Planned End Date changed from 1 Mar 2028 to 1 Aug 2028.
  • 06 Apr 2026 Planned primary completion date changed from 1 Dec 2027 to 1 Nov 2027.

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