A Phase I Study of BC2059 (Tegavivint) in Patients with Inoperable Desmoid Tumors

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Phase 1 Trial of BC2059 (Tegavivint) in Patients with Unresectable Desmoid Tumor

Purpose

The purpose of this study is to find the highest dose of an investigational drug called BC2059 (tegavivint) that can be given safely in patients with desmoid tumors that are growing but cannot be surgically removed. BC2059 blocks a process inside cells that allows a protein called beta catenin to build up without being broken down or cleared away. In desmoid tumors, it is harder for a cell to protect itself against this dangerous build-up of beta catenin proteins, which may cause the cells to become cancerous.

BC2059 enables other proteins in cells to destroy beta catenin before it piles up. Laboratory studies of BC2059 have shown that the drug can shrink or slow the growth of desmoid tumors. BC2059 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 inoperable desmoid tumor that is continuing to grow.
  • Patients must recover from the serious side effects of prior treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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. Mrinal Gounder at 646-888-4167.

Protocol

18-425

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators