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A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

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

Record History

  1. Study sites: 78 to 79 Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 5 of 5 entries · Study description expanded, about 2 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description expanded, about 2 words
  2. Trial sites expanded: 68 → 78 locationsv16
  3. Trial sites expanded: 56 → 68 locationsv15
  4. Primary completion pushed from May 2028 to Aug 2029 Trial sites expanded: 41 → 56 locations · Completion pushed from May 2029 to Aug 2029v14 Show 2 more changesShow less
    • Trial sites expanded: 41 → 56 locations
    • Completion pushed from May 2029 to Aug 2029
  5. Study sites: 39 to 41 Eligibility criteria expanded, about 9 words · Study description shortened, about 16 words · Collaborators: 3 to 2v13 Show 3 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Study description shortened, about 16 words
    • Collaborators: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  6. Trial sites expanded: 34 → 39 locationsv12
  7. Study sites: 20 to 34v11
  8. Study sites: 18 to 20v10
  9. Study sites: 15 to 18 Collaborators: 2 to 3v9 Show 1 more changeShow less
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 14 to 15v8
  11. Study sites: 10 to 14 Collaborators: 3 to 2v7 Show 1 more changeShow less
    • Collaborators: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 9 to 10v6
  13. Study sites: 7 to 9v5
  14. Study sites: 4 to 7v4
  15. Enrollment target: 320 to 380 Study sites: 2 to 4 · Primary completion date: Mar 2028 to May 2028 · Completion date: Sep 2032 to May 2029 · 5 morev3 Show 8 more changesShow less
    • Study sites: 2 to 4
    • Primary completion date: Mar 2028 to May 2028
    • Completion date: Sep 2032 to May 2029
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description expanded, about 26 words
    • Collaborators: 2 to 3
    • Study arms: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  16. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Apr 2025 to Apr 23, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Apr 2025 to Apr 23, 2025
  17. 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
Breast Cancer
5,213 trials monitored
See 271 trials at risk
This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).
Trial Details
NCT Number NCT06827236
Lead Sponsor BioNTech SE
Collaborators: DualityBio Inc., BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Conditions Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer
Enrollment 380 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov