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Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jun 2027 to Aug 18, 2026 Completion moved earlier from Mar 2028 to Nov 2026 · Eligibility criteria expanded, about 64 words · Secondary endpoints: details revised at 3 of 7 entries · 1 more Show 4 more changesShow less
    • Completion moved earlier from Mar 2028 to Nov 2026
    • Eligibility criteria expanded, about 64 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Study description revised
  2. Primary completion date: Sep 2026 to Jun 2027 Primary endpoints revised (4) · Completion date: Sep 2026 to Mar 2028 · Secondary endpoints revised (7) · 2 morev16 Show 5 more changesShow less
    • Primary endpoints revised (4)
    • Completion date: Sep 2026 to Mar 2028
    • Secondary endpoints revised (7)
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 103 to confirmed 41 · Site details revised at 14 of 14 sitesv15 Show 2 more changesShow less
    • Enrollment target: estimated 103 to confirmed 41
    • Site details revised at 14 of 14 sites
  4. Phase: Phase 1/2 to Phase 1 Enrollment target: 360 to 103 · Primary endpoints: 9 to 4 · Primary and study completion dates: Jul 2027 to Sep 2026 · 6 morev14 Show 9 more changesShow less
    • Enrollment target: 360 to 103
    • Primary endpoints: 9 to 4
    • Primary and study completion dates: Jul 2027 to Sep 2026
    • Interventions: BNT314 (Biological), Pembrolizumab (Biological) to BNT314 (Biological)
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: 21 to 7
    • Study description shortened, about 43 words
    • Study title shortened, about 7 words
    • Study arms: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 13 to 14v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 9 to 13v12
  2. Study sites: 6 to 9v11
  3. Primary and study completion dates: Feb 2030 to Jul 2027 Site details revised at 2 of 6 sitesv10 Show 1 more changeShow less
    • Site details revised at 2 of 6 sites
  4. Study sites: 5 to 6v9
  5. Study sites: 4 to 5v8
  6. Re-verified, no change to tracked fieldsv7
  7. Site details revised at 1 of 4 sitesv6
  8. Study sites: 3 to 4v5
  9. Re-verified, no change to tracked fieldsv4
  10. Study sites: 2 to 3v3
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2 · Start date changed from estimate of Dec 1, 2023 to Nov 30, 2023v2 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Dec 1, 2023 to Nov 30, 2023
  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
The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer. This is a dose escalation study in which patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose will be investigated.
Trial Details
NCT Number NCT06150183
Lead Sponsor BioNTech SE
Collaborators: Genmab
Conditions Advanced Malignant Solid Tumor
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov