A Phase 1b/2 Study of Disitamab Vedotin With Tucatinib in People With Solid Tumors

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Full Title

A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination with Other Anticancer Therapies in Solid Tumors

Purpose

Researchers want to see if disitamab vedotin plus tucatinib is safe and works well in people with advanced solid tumors. They want to find the best dose of disitamab vedotin to give with tucatinib. The people in this study have different types of HER2-positive and HER2-low solid tumors, including breast cancer.

The HER2 protein plays a role in cancer growth and survival. When people have HER2-positive cancer, their cancer cells have high levels of HER2 on them. When people have HER2-low cancer, their cancer cells have low levels of HER2 on them.

Disitamab vedotin targets cells with HER2. By destroying these cells, disitamab vedotin may help slow or stop the growth of your cancer. Tucatinib blocks enzymes called tyrosine kinases that fuel cancer growth.

If you join this study, you will get both disitamab vedotin and tucatinib. Disitamab vedotin is given intravenously (by vein) and tucatinib is taken orally (by mouth).

Who Can Join

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

  • Have HER2-positive or HER2-low breast cancer or other solid tumor that has spread or cannot be removed with surgery.
  • Have completed prior anti-cancer therapies at least 4 weeks 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. Shanu Modi’s office at 646-888-4564.

Protocol

24-306

Phase

Phase I/II (phases 1 and 2 combined)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06157892