A Phase 1 Study of Valemetostat Tosylate in Combination With Dato-DXd in People With Lung Cancer and With T-DXd in People With Digestive Cancers

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Full Title

A Phase 1b, Multicenter, Open-label Study of Valemetostat Tosylate in Combination with DXd ADCs in Subjects with Solid Tumors

Purpose

Researchers are finding the best doses of valemetostat tosylate and datopotamab deruxtecan (Dato-DXd) to use in people with lung cancer. In a second part of the study, researchers are finding the best doses of valemetostat tosylate and trastuzumab deruxtecan (T-DXd) to use in people with digestive cancers.

The people with lung cancer have non-small cell lung cancer that is inoperable (not removable with surgery) or has spread. The people with digestive cancers have advanced gastric (stomach) or gastro-esophageal junction (GEJ) cancer.

Valemetostat tosylate blocks proteins called EZH1 and EZH2, which play a role in cancer growth and survival. Dato-DXd targets cancer cells with a high level of a protein called TROP2. T-DXd targets cells that make the HER2 protein, which plays a role in cancer cell growth. These medications are given intravenously (by vein).

Who Can Join

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

  • Have inoperable or metastatic non-small cell lung cancer, stomach cancer, or GEJ cancer.
  • Have recovered from the serious side effects of prior anti-cancer treatments before getting the study therapy.
  • 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. Alissa Cooper’s office at 646-608-4322.

Protocol

24-239

Phase

Phase I (phase 1)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06244485