A Phase 1b Study of Bulumtatug Fuvedotin in People With Triple-Negative Breast Cancer

Full Title

An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BF, 9MW2821) in Subjects with Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated with Antibody-Drug Conjugates

Purpose

Researchers want to see if bulumtatug fuvedotin works well against breast cancer. The people in this study have triple-negative breast cancer (TNBC) that came back or spread after treatment. 

TNBC is not fueled by estrogen or progesterone and does not have the HER2 protein. As a result, it cannot be treated with medications that target those proteins.

Bulumtatug fuvedotin is an antibody-drug conjugate (ADC). ADCs are made of an antibody linked to an anti-cancer drug. The antibody part binds to certain proteins on cancer cells. The linked drug then enters these cells and kills them, with a reduced risk of harming other cells. Bulumtatug fuvedotin is given intravenously (by vein).

Who Can Join

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

  • Have TNBC that spread or came back after up to 3 prior regimens of therapy that included chemotherapy and ADCs.
  • Have completed previous treatments at least 4 weeks before getting bulumtatug fuvedotin.
  • 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. Nour Abuhadra’s office at 646-888-4451.

Protocol

25-143

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT06908928