RecruitingCancer Harboring BRAF AlterationsHGGLGG

A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations

Eligible age

8+ yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

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About this study

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.

Sponsor: Fore Biotherapeutics

You may qualify if…

✓ Subprotocol A:
✓ 1. Male and female, ≥8 years of age, and weighing ≥25 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 treatment with standard therapy is not appropriate.
✓ 7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.

You may not qualify if…

✕ Subprotocol A:
✕ 1. Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease.
✕ 2. Prior treatment with a MEK inhibitor.
✕ 3. 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.
✕ 4. Malignancy with co-occurring activating RAS mutation(s) at any time.
✕ 5. Uncontrolled intercurrent illness that would limit compliance with study requirements.
✕ 6. HIV infection with exceptions; discuss with treating physician.
✕ 7. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection).