FORE-8394 clinical trial
PLX 120-03: A Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PLX8394 in Patients with Advanced, Unresectable Solid Tumors.
The purpose of this study is to assess the safety and effectiveness of the investigational drug FORE-8394 (previously PLX-8394) 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. FORE-8394 works by preventing these altered BRAF proteins from working, thereby blocking the growth and spread of cancer cells.
In this study, patients will receive FORE-8394 in combination with cobicistat, a drug used to increase the amount of FORE-8394 in the blood to make it more effective. Both drugs are tablets that are taken orally (by mouth).
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.