A Phase 1-2 Study of BNT323 and BNT327 in People With Breast Cancer

Full Title

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination with BNT327 in Participants with Advanced Breast Cancer

Purpose

Researchers want to find the best doses of BNT323 and BNT327 to treat breast cancer. The people in this study have breast cancer that has spread and keeps growing after treatment.

BNT323 is an antibody-drug conjugate. It is made up of an antibody and a chemotherapy drug. The antibody attaches to the HER2 protein on cancer cells. Once attached, the chemotherapy enters the cells and causes them to die, preventing tumor growth.

BNT327 is a bispecific antibody. It binds to and blocks the function of two proteins: PD-L1 and VEGF-A. BNT327 could boost your immune system, reduce blood supply to the tumor, and reduce tumor spread. Both BNT323 and BNT327 are given intravenously (by vein).

Contact

For more information about this study or to see if you can join, please call Dr. Shanu Modi’s office at 646-888-4564.

Protocol
25-271
Phase
Phase I/II (phases 1 and 2 combined)
Disease Status
Relapsed or Refractory
Investigator
Co-Investigators
Diseases
ClinicalTrials.gov ID
NCT06827236