A Phase I Study of RO7293583 Immunotherapy in People with TYRP1-Positive Melanoma

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Full Title

An Open-label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7293583, A TYRP1 Targeting CD3 T-Cell Engager in Participants with Metastatic Melanoma

Purpose

The purpose of this study is to assess the safety of the investigational immunotherapy RO7293583 in patients with metastatic melanoma that contains a protein called TYRP-1. RO7293583 is an antibody designed to attach to two different types of cells at the same time, enabling these cells to be brought close to each other. One of these cells is the melanoma cell that expresses TYRP1, and the other is a T cell from the immune system that fights the melanoma cells. RO7293583 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 stage III or metastatic (stage IV) skin or eye (uveal) melanoma who cannot be effectively treated with standard therapies.
  • At least 4 weeks must pass since the completion of prior therapies and receipt of RO7293583.
  • 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. Margaret Callahan at 646-888-5108.

Protocol

21-121

Phase

I

Investigator

Co-Investigators