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A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

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

Record History

  1. Study sites: 76 to 77 Eligibility criteria expanded, about 67 words · Secondary endpoints: details revised at 11 of 17 entries · Study description expanded, about 13 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 67 words
    • Secondary endpoints: details revised at 11 of 17 entries
    • Study description expanded, about 13 words
  2. Trial sites expanded: 67 → 76 locationsv11
  3. Enrollment increased: 980 → 1438 participants Trial sites expanded: 64 → 67 locations · Completion pushed from Oct 2029 to Mar 2030 · Trial arms changed: 16 → 18 · 4 morev10 Show 7 more changesShow less
    • Trial sites expanded: 64 → 67 locations
    • Completion pushed from Oct 2029 to Mar 2030
    • Trial arms changed: 16 → 18
    • Primary completion date: Feb 2028 to Mar 2028
    • Eligibility criteria shortened, about 28 words
    • Secondary endpoints: details revised at 1 of 17 entries
    • Study description expanded, about 57 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial sites expanded: 53 → 64 locationsv9
  5. Study sites: 39 to 53v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 38 to 39v7
  2. Enrollment target: 550 to 980 Primary endpoints revised (6) · Primary completion date: May 2028 to Feb 2028 · Completion date: Feb 2030 to Oct 2029 · 6 morev6 Show 9 more changesShow less
    • Primary endpoints revised (6)
    • Primary completion date: May 2028 to Feb 2028
    • Completion date: Feb 2030 to Oct 2029
    • Interventions: BNT326 (Drug), BNT327 (Drug), Itraconazole (Drug), Paroxetine (Drug) to BNT326 (Drug), Itraconazole (Drug), Paroxetine (Drug), Pumitamig (Drug)
    • Eligibility criteria expanded, about 215 words
    • Secondary endpoints revised (17)
    • Study description expanded, about 147 words
    • Study arms: 9 to 16
    • Collaborators expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 18 to 38v5
  4. Study sites: 9 to 18v4
  5. Study sites: 7 to 9v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 7 · Start date changed from estimate of Jul 2025 to Aug 12, 2025 · Collaborators shortened, about 7 wordsv2 Show 3 more changesShow less
    • Study sites: 0 to 7
    • Start date changed from estimate of Jul 2025 to Aug 12, 2025
    • Collaborators shortened, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  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 study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.
Trial Details
NCT Number NCT07070232
Lead Sponsor BioNTech SE
Collaborators: BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Conditions Advanced Solid Tumor
Enrollment 1,438 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov