A Phase I Study Assessing the Immunomodulatory Activity of LY2157299 in Patients with Advanced Solid Tumors

Full Title

Phase 1 Study to Determine the Immunomodulatory Activity of LY2157299 Monohydrate in Patients with Solid Tumors

Purpose

LY2157299 is an investigational drug designed to provoke the immune system to attack cancer cells by blocking a substance called transforming growth factor-beta. The optimal dose of LY2157299 has been determined by prior studies. In this study, researchers want to observe how LY2157299 affects the immune system and its ability to attack and kill cancer cells in patients with advanced solid tumors that have persisted despite previous treatment. LY2157299 is taken orally (by mouth).

This study requires patients to have blood tests during the study as well as two biopsies of tumor tissue: one before treatment with LY2157299 begins, and a second biopsy six weeks into treatment. The analysis of the tumor biopsies and the blood test results will provide researchers with information about the immune-stimulating activity of LY2157299.

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 has come back or continued to grow despite at least one prior regimen of therapy.
  • At least 4 weeks must pass between completion of prior treatment and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Hellmann at 646-888-4863.

Protocol

14-117

Phase

I

Investigator

Co-Investigators

Locations