A Phase 2 Study of BDC-1001 Alone or With Pertuzumab in People With Metastatic Breast Cancer

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Full Title

A Phase 2, Multi-Center, Randomized, Open-Label Trial of BDC-1001 as Single Agent and in Combination with Pertuzumab in Subjects with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Previously Treated with Trastuzumab Deruxtecan

Purpose

Researchers want to see if BDC-1001, alone or with pertuzumab, is safe and works well against advanced breast cancer. The people in this study have breast cancer that has metastasized (spread) and makes the HER2 protein (HER2-positive). In addition, they have previously been treated with trastuzumab deruxtecan.

BDC-1001 boosts the immune system and may work against cancers that keep growing after trastuzumab. By combining BDC-1001 with pertuzumab, BDC-1001 may kill more cancer cells. If you join this study, you will be randomly assigned to get BDC-1001 alone or with pertuzumab. Both drugs are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic HER2-positive breast cancer that keeps growing after trastuzumab deruxtecan treatment.
  • Have recovered from the serious side effects of prior therapies before getting the study treatment.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Joshua Drago’s office at 646-888-6971.

Protocol

23-292

Phase

Phase II (phase 2)

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT05954143