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

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 brea

Trial Details

NCT ID
NCT06827236
Phase
PHASE1 / PHASE2
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • BNT323
  • BNT327
Locations (sample)
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Port Saint Lucie, Florida, United States|27.29393,-80.35033
  • Athens, Georgia, United States|33.96095,-83.37794
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Grand Rapids, Michigan, United States|42.96336,-85.66809

Key Eligibility Criteria

  • Have pathologically documented BC that:
  • Is locally advanced, unresectable or metastatic.
  • Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior to study screening (Part 1, Part 2 Cohorts 2 an…
  • Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or T…

For full eligibility, visit ClinicalTrials.gov.

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