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
Trial status:Will Be Recruiting
Trial ID:
BNT323-03
NCT ID:
EudraCT ID:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Will Be Recruiting
Trial Details
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 in combination with BNT327 in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining), or HER2-null breast cancer (BC).
Medical Condition
Trial Drug
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Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
320
Estimated Trial Date
Apr 2025 - Mar 2028
Trial Participant Requirements
Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Trial Locations
No locations found.