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

Sponsor
BioNTech SE
Study ID
NCT07147348
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BNT3212 — BIOLOGICAL
    Intravenous infusion
  • Pumitamig — BIOLOGICAL
    Intravenous infusion

Study Details

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.

Key Dates

Start date
Aug 27, 2025
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
375 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - BNT3212 monotherapy (dose escalation)
    Escalating dose levels of BNT3212 to define the maximum tolerated dose (MTD) in participants with histologically or cytologically confirmed locally advanced/unresectable, recurrent, or metastatic malignant solid tumors who are refractory to or unable to tolerate standard treatment, or for whom no standard treatment is available.
  • Experimental: Part B - BNT3212 monotherapy dose level (DL)1 (expansion cohort)
    Indication-specific cohort populations will be tested.
  • Experimental: Part B - BNT3212 monotherapy DL2 (expansion cohort)
    Indication-specific cohort populations will be tested.
  • Experimental: Part B - BNT3212 monotherapy DL3 (expansion cohort)
    Indication-specific cohort populations will be tested.
  • Experimental: Part C - BNT3212 + pumitamig combination therapy (dose escalation)
    Escalating dose levels of BNT3212 plus a fixed dose of pumitamig to define the MTD in participants with histologically or cytologically confirmed locally advanced/unresectable, recurrent, or metastatic malignant solid tumors who are refractory to or unable to tolerate standard treatment, or for whom no standard treatment is available.
  • Experimental: Part D - BNT3212 DL1 + pumitamig combination therapy (expansion cohort)
    Indication-specific cohort populations will be tested. Pumitamig will be administered as fixed dose.
  • Experimental: Part D - BNT3212 DL2 + pumitamig combination therapy (expansion cohort)
    Indication-specific cohort populations will be tested. Pumitamig will be administered as fixed dose.
  • Experimental: Part D - BNT3212 DL3 + pumitamig combination therapy (expansion cohort)
    Indication-specific cohort populations will be tested. Pumitamig will be administered as fixed dose.

Primary Outcome Measure

Parts A and C - Occurrence of dose limiting toxicities (DLTs) within a participant during the DLT observation period [ Time Frame: Up to 28 days after first dose of investigational medicinal product (IMP). ]

Central Contacts

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