Plixorafenib for Cancers with BRAF Alterations

This study is testing a drug called plixorafenib in people with cancer that has specific changes in the BRAF gene (BRAF V600E or BRAF fusions). This includes advanced solid tumors or brain and spinal cord tumors. The study aims to see how well plixorafenib works to shrink tumors and if it is safe. To join, you must be at least 8 years old and weigh at least 25 kg, and your tumor must have a BRAF gene alteration. The study plans to enroll 254 participants, but its current status is unclear. Researchers will measure how many people respond to the treatment over about four years.

Study design
This interventional study is evaluating plixorafenib in 254 planned participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure how well the treatment works and how the drug moves through the body for up to approximately 4 years.

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NCT05503797

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

Recruiting
PHASE2Ages 8+InterventionalTreatment
Fore Biotherapeutics
~254 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Plixorafenib

At a glance

Recruiting sites
67 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) (Subprotocols A, B and C)
Measured over Up to approximately 4 years
+1 more outcome measured
Cancer Harboring BRAF Alterations
HGG
LGG
Solid Tumors
70 sites across 54 states
Ohio4
California3
Massachusetts3
Texas3
New South Wales3
Maryland2
New York2
Tennessee2

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Eligibility criteria

Inclusion

Note: Participants who have a WHO Grade 3 or 4 glioma for whom chemotherapy and/or radiotherapy is not considered standard of care may remain eligible for the study.
  • Objective Response Rate (ORR) (Subprotocols A, B and C)Up to approximately 4 years

    ORR will be determined by standard tumor response criteria by blinded independent central review (BICR).

  • Pharmacokinetics (Subprotocol D)Up to approximately 4 years

    Systemic exposure of plixorafenib measured by Cmax and AUC