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Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site details revised at 2 of 16 sitesv5
  2. Minor Trial sites expanded: 5 → 16 locationsv4
  3. Minor Study sites: 4 to 5v3
  4. Notable Recruitment opened Trial sites expanded: 0 → 4 locations · Start date changed from estimate of Mar 2026 to Mar 30, 2026v2 Show 2 more changesShow less
    • Trial sites expanded: 0 → 4 locations
    • Start date changed from estimate of Mar 2026 to Mar 30, 2026
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
49 trials monitored
See 3 trials at risk
This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. The first two parts (Parts A and B) will focus on testing different amounts of BNT3214 to figure out the best and safest dose. The third part (Part C) will test selected doses of BNT3214 in multiple types of cancer.
Trial Details
NCT Number NCT07455734
Lead Sponsor BioNTech SE
Collaborators: BioNTech (Shanghai) Pharmaceuticals Co., Ltd., Biotheus (Hengqin) Co., Ltd.
Conditions Advanced Solid Tumor Cancer
Enrollment 533 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov