A Phase II Study of T-DXd in People with Advanced Solid Tumors Driven by Abnormal HER2

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Full Title

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology

Purpose

The purpose of this study is to assess the safety and effectiveness of trastuzumab deruxtecan (T-DXd) in patients with advanced solid tumors whose growth is driven by an abnormal form of the HER2 protein, known as an “activating HER2 mutation.” T-DXd 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. When trastuzumab sticks to HER2, deruxtecan (the cell-killing chemotherapy part) is released and kills the cancer cell from within. T-DXd is approved to treat metastatic breast, stomach, and gastroesophageal junction cancers; 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 solid tumors that have continued to grow despite standard treatment or for which no standard treatment exists.
  • Patients’ tumors must make abnormal HER2 with any of the following HER2 mutations: S310F, S310Y, G660D, R678Q, D769Y, D769H, V777L, Y772_A775dup/A775_G776insYVMA, L755S, G778_P780dup/P780_Y781insGSP, T862A, or V842I. 
  • Patients should recover from the serious side effects of previous treatments before receiving T-DXd.
  • 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. Bob Li at 646-888-4226.

Protocol

21-239

Phase

II

Investigator