A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10+
SponsorFore Biotherapeutics
About this trial
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 criteria
Qualifiers
Male and female, ≥10 years of age, and weighing ≥30 kg.
Histologic diagnosis of a solid tumor or primary CNS tumor.
Documentation of BRAF gene fusion in tumor and/or blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing.
Have an archival tissue sample available meeting protocol requirements.
Disqualifiers
Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease.
Prior treatment with a MEK inhibitor.
Tyrosine kinase inhibitor(s) and/or targeted therapies are allowed (other than BRAF/MAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines.
Malignancy with co-occurring activating RAS mutation(s) at any time.
Trial design
Treatments tested in this trial
- Plixorafenib
Treatment groups
254 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov