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A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 4 of 4 changed
See other at-risk trials from BioNTech SE

Record History

  1. Minor Study sites: 16 to 17v7
  2. Notable Primary endpoint(s) modified Trial sites expanded: 10 → 16 locations · Eligibility criteria shortened, about 8 words · Secondary endpoints: 9 to 11 · 1 morev6 Show 4 more changesShow less
    • Trial sites expanded: 10 → 16 locations
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 9 to 11
    • Study description expanded, about 43 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study sites: 8 to 10v5
  4. Minor Trial sites expanded: 4 → 8 locationsv4
  5. Minor Study sites: 1 to 4v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 2025 to Nov 18, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2025 to Nov 18, 2025
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are. The second goal of this study is to evaluate how well BNT329 works. This will be done by measuring the number of participants who respond to the treatment. The length of time where the tumor does not grow or spread will also be measured. The study will also evaluate how BNT329 moves into, through, and out of the body and how the treatment affects the body.
Trial Details
NCT Number NCT07186842
Lead Sponsor BioNTech SE
Conditions Advanced Solid Cancers
Enrollment 245 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov