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Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 9 months later Jun 2028 → Apr 2031
Primary endpoint reworded 4 of 4 changed
See other at-risk trials from BioNTech SE

Record History

  1. Primary and study completion pushed from Jun 2028 to Apr 2031 Primary endpoint(s) modified · Phase changed: Phase 1 → Phase 1/2 · Enrollment increased: 39 → 248 participants · 6 morev9 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Phase 1 → Phase 1/2
    • Enrollment increased: 39 → 248 participants
    • Interventions modified
    • Trial arms changed: 7 → 11
    • Eligibility criteria expanded, about 559 words
    • Secondary endpoints: 9 to 10
    • Study description expanded, about 201 words
    • Site details revised at 6 of 11 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 9 to 11v8
  3. Study sites: 8 to 9v7
  4. Study sites: 7 to 8v6
  5. Study sites: 6 to 7v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 4 to 6 Eligibility criteria expanded, about 27 words · Secondary endpoints revised (9) · Study description expanded, about 35 wordsv4 Show 3 more changesShow less
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 35 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 3 to 4v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Jan 2025 to Jan 13, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Jan 2025 to Jan 13, 2025
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This is a first-in-human (FIH), open-label, multi-site study which will evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.
Trial Details
NCT Number NCT06750185
Lead Sponsor BioNTech SE
Conditions Advanced Solid Tumor
Enrollment 248 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov