A Phase I Study of Oral RGX-104 Immunotherapy for Patients with Recurrent or Persistent Advanced Solid Tumors and Lymphoma

Full Title

RGX-104-001: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy drug RGX-104 that can be given safely in people with advanced solid tumors or lymphoma that have come back or continued to grow despite therapy. RGX-104 boosts the power of the immune system against cancer by inhibiting a family of proteins called LiverX receptors (LXRs), which enable cancer cells to escape detection and destruction by the immune system.

RGX-104 slowed tumor growth or shrank tumors in laboratory studies. It is taken orally (by mouth).

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 (such as melanoma, non-small cell lung cancer, ovarian cancer, or breast cancer) or lymphoma that is locally advanced or metastatic and has come back or continued to grow despite prior treatment.
  • At least 2 weeks must pass since the completion of prior therapies and entry into 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 and to inquire about eligibility for this study, please contact Dr. Michael Postow at 646-888-4593.

Protocol

17-006

Phase

I

Investigator

Co-Investigators