A Phase II Study of AL102 in People Who Have Desmoid Tumors That Are Growing

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Full Title

RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL 102 in Patients with Progressing Desmoid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug AL102 that can be given safely in patients with desmoid tumors that continue to grow. Researchers will also assess its effectiveness.

Desmoid tumors are tumors in tissue that connects the bones, ligaments, and muscles to the organs in the body. These tumors can grow into nearby organs and structures, most often in the abdomen, arms, and legs.

AL102 blocks a chemical pathway in cells that allows desmoid tumors to grow. Blocking this pathway may stop the tumor from growing and/or cause it to shrink. AL102 is taken orally (by mouth).

Eligibility

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

  • Participants must have a desmoid tumor that is either previously untreated and inoperable, or has come back or continued to grow after prior treatment.
  • At least 4 weeks must pass between the completion of previous therapy and receipt of AL102.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people 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

21-333

Phase

II/III

Investigator

Co-Investigators