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
Age8+
SponsorFore Biotherapeutics
About this trial
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors, including rare BRAF V600E-mutated solid tumors, including anaplastic thyroid, ovarian, cholangiocarcinoma or other rare cancers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female, ≥8 years of age, and weighing ≥25 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
Design model
Parallel
Treatments tested in this trial
Plixorafenib
DrugOral tablets
Treatment groups
254 Participants
are divided into 4 treatment groupsGroup A: Subprotocol AExperimental treatment 1 intervention
Group B: Subprotocol BExperimental treatment 1 intervention
Group C: Subprotocol CExperimental treatment 1 intervention
Group D: Subprotocol DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) (Subprotocols A, B and C)
ORR will be determined by standard tumor response criteria by blinded independent central review (BICR).
Time frame
Up to approximately 4 years2
Pharmacokinetics (Subprotocol D)
Systemic exposure of plixorafenib measured by Cmax and AUC
Time frame
Up to approximately 4 yearsSecondary outcomes
1
Duration of Response (DOR) by BICR (Subprotocols A, B and C)
DOR will be determined by standard tumor response criteria per BICR (subprotocols A-C)
Time frame
Up to approximately 4 years2
ORR per Investigator Assessment
ORR will be determined by standard tumor response criteria by Investigator Assessment.
Time frame
Up to approximately 4 years3
DOR per Investigator Assessment
DOR will be determined by standard tumor response criteria.
Time frame
Up to approximately 4 years4
Percentage of Participants with DOR at 6 months, 12 months, and 18 months
Time frame
6 months, 12 months and 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov