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A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

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

Record History

  1. Study sites: 16 to 17v4
  2. Primary endpoints: 4 to 5 Study sites: 2 to 16 · Primary completion date: Dec 2027 to Nov 2027 · Completion date: Mar 2028 to Aug 2028 · 4 morev3 Show 7 more changesShow less
    • Study sites: 2 to 16
    • Primary completion date: Dec 2027 to Nov 2027
    • Completion date: Mar 2028 to Aug 2028
    • Interventions: BNT3212 (Biological), BNT327 (Biological) to BNT3212 (Biological), Pumitamig (Biological)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 11 to 10
    • Study description expanded, about 30 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Aug 2025 to Aug 27, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Aug 2025 to Aug 27, 2025
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
BioNTech SE
49 trials monitored
See 3 trials at risk
The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with pumitamig (also known as BNT327 or PM8002) as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options.
Trial Details
NCT Number NCT07147348
Lead Sponsor BioNTech SE
Collaborators: Biotheus (Hengqin) Co., Ltd., BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Conditions Advanced Solid Tumor
Enrollment 375 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov