A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations
Fore Biotherapeutics
Summary
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutated solid tumors, melanoma, thyroid, or recurrent primary CNS tumors.
Eligibility
- Age range
- 10+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria Subprotocol A: 1. Male and female, ≥10 years of age, and weighing ≥30 kg. 2. Histologic diagnosis of a solid tumor or primary CNS tumor. 3. Documentation of BRAF gene fusion in tumor and/or blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing. 4. Have an archival tissue sample available meeting protocol requirements. 5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory. 6. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that trea…
Interventions
- DrugPlixorafenib
Oral tablets
Locations (67)
- Precision NextGen Oncology & Research CenterBeverly Hills, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- University of California Los Angeles RheumatologyWestwood, Los Angeles, California
- Norwalk HospitalNorwalk, Connecticut
- University of Miami Hospital and ClinicsMiami, Florida
- The John Hopkins HospitalBaltimore, Maryland