A Phase II Study of Trastuzumab Deruxtecan in People with HER2-Positive Solid Tumors

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Full Title

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2-expressing Tumors (DESTINY-PanTumor02)

Purpose

The purpose of this study is to assess the safety and effectiveness of the drug trastuzumab deruxtecan (also known as DS-8201A) in patients with inoperable or metastatic solid tumors that produce too much of a protein called HER2, including biliary tract, bladder, cervical, endometrial, ovarian, and pancreatic cancers.

Trastuzumab deruxtecan is an antibody drug conjugate (ADC). ADCs have two parts: the antibody targets cancer cells and the other part (a chemotherapy drug attached to the antibody) kills cancer cells. Trastuzumab, the antibody part, binds to HER2 on cancer cells. Deruxtecan is the cell-killing part. When trastuzumab sticks to HER2, deruxtecan is released and kills the cancer cell from within.

Trastuzumab deruxtecan is approved to treat metastatic breast cancer; its use in this study is investigational. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic HER2-positive biliary tract, bladder, cervical, endometrial, ovarian, or pancreatic cancer or a rare tumor.
  • At least 4 weeks must pass since completion of prior therapy and receipt of trastuzumab deruxtecan.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Vicky Makker at 646-888-4224.

Protocol

21-078

Phase

II

Investigator

Co-Investigators