A Phase 1 Study of DS-2243a in People With Advanced Solid Tumors

Full Title

Phase 1, Open-label, Multicenter, First-in-human Trial of DS-2243a in Participants with Advanced Solid Tumors

Purpose

Researchers want to find the best dose of DS-2243a to use in people with solid tumors. The people in this study have these solid tumors, which have spread beyond their original location:

  • Synovial sarcoma
  • Myxoid/round cell liposarcoma
  • Urothelial cancer

In addition, they have the HLA-A2 protein in their blood. If they have urothelial cancer, their tumors make a protein called NY-ESO.

DS-2243a is a bispecific antibody, which binds to two different proteins. The drug binds to one protein on the surface of cancer cells and one on immune cells. DS-2243a may strengthen your immune system’s ability to fight cancer cells by activating your own cells to destroy the tumor. It is given as a subcutaneous (under the skin) injection.

Who Can Join

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

  • Have one of the cancers listed above, which has spread and cannot be treated with standard therapies.
  • Have HLA-A2 in your blood and, if you have urothelial cancer, a tumor that makes NY-ESO.
  • Have recovered from the serious side effects of prior therapies before getting DS-2243a.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Sandra D’Angelo’s office 646-888-4159.

Protocol

25-045

Phase

Phase I (phase 1)

Investigator

ClinicalTrials.gov ID

NCT06644755