A Phase 1 Study of D3L-001 in People With Advanced Breast Cancer

Full Title

A Phase 1, Open-label Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects with HER2-Positive Advanced Solid Tumors

Purpose

Researchers want to find the best dose of D3L-001 to treat advanced breast cancer. The people in this study have breast cancer that cannot be cured with standard therapies. Their tumors also make the HER2 protein, which plays a role in cancer growth.

D3L-001 is a drug that binds to two proteins. One protein is found on the surface of cancer cells, and the other is on immune cells called T cells. D3L-001 may strengthen your immune system’s ability to fight cancer cells by helping your own cells to destroy your tumor. It is given intravenously (by vein).

Who Can Join

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

• Have metastatic or locally advanced breast cancer that keeps growing after treatment or cannot be treated using standard therapies.
• Have breast cancer that makes HER2.
• Have recovered from the serious side effects of prior therapies before getting D3L-001.
• 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. Shanu Modi’s office at 646-344-2550.