A Phase I/II Study of DS-7300a in People with Advanced Solid Tumors

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Full Title

Phase I/II, Two-Part, Multicenter First-in-Human Study of DS-7300a in Subjects with Advanced Solid Malignant Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug DS-7300a that can be given safely in patients with advanced solid tumors. DS-7300a is an antibody-drug conjugate. The antibody part binds to a protein called BH-73, which many advanced solid tumors make and which helps them survive and grow. Once bound to a cancer cell, the drug part of DS-7300a is released and kills cancer cells. DS-7300a 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 an advanced solid tumor that cannot be successfully treated with standard therapies. Examples include head and neck cancers, esophageal cancer, non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, prostate cancer, and breast cancer.
  • Patients should recover from the serious side effects of previous treatments before receiving DS-7300a.
  • 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. Claire Friedman at 646-888-4247.

Protocol

20-516

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators