A Phase I/IIA Study of PLX8394 in Patients with Advanced Inoperable Solid Tumors

Full Title

PLX120-03: A Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of FORE8394 in Patients with Advanced, Unresectable Solid Tumors

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug PLX8394 in patients with advanced, inoperable solid tumors that contain an altered form of a gene called BRAF. Certain mutations or “transfusions” in the BRAF gene cause a change in the BRAF protein that can promote cancer growth and spread. PLX8394 works by preventing these altered BRAF proteins from working, thereby blocking the growth and spread of cancer cells.

In this study, patients will receive PLX8394 in combination with cobicistat, a drug used to increase the amount of PLX8394 in the blood to make it more effective. Both drugs are tablets that are taken orally (by mouth).

Who Can Join

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

• Patients must have an advanced, inoperable solid tumor with a BRAF mutation. Examples include pediatric brain tumors, Langerhans cell histiocytosis, or any advanced inoperable solid tumor containing this mutation.
• Patients’ cancers must persist despite prior therapy or be considered incurable using standard therapies.
• Patients must be able to walk and do routine activities for more than half of their normal waking hours.
• This study includes children and adults ages 3 years and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eric Sherman at 646-888-4234.