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

Conditions

• Cancer Harboring BRAF Alterations
• HGG
• LGG
• Solid Tumors

Eligibility Criteria

Sex

ALL

Age

10 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Plixorafenib — DRUG
  Oral tablets

Study Details

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.

Key Dates

Start date

Feb 21, 2023

Status verified

Jun 2026

Primary completion

Jun 27, 2026

Completion

Dec 28, 2026

Study Design

Enrollment

254 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Subprotocol A
  Participants with unresectable, locally advanced or metastatic solid tumors or primary CNS tumors harboring BRAF fusions will receive plixorafenib which will be increased as tolerated, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.
• Experimental: Subprotocol B
  Participants with recurrent primary CNS tumors harboring BRAF V600E mutations will receive plixorafenib, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.
• Experimental: Subprotocol C
  Participants with advanced, rare, non-CNS solid tumors harboring BRAF V600E mutations will receive plixorafenib, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.
• Experimental: Subprotocol D
  Participants with BRAF V600E-mutated advanced solid tumors will receive plixorafenib until disease progression, unacceptable toxicity, or other reason for withdrawal.

Primary Outcome Measure

Objective Response Rate (ORR) (Subprotocols A, B and C) [ Time Frame: Up to approximately 4 years ]

Central Contacts

• Jessica Rine
  610-442-4517
  [email protected]
• Geri Bardelli
  978-835-2310
  [email protected]

Locations (30)

Find similar trials in Beverly Hills, CA

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