NCT06104488

A Study of Avutometinib for People With Solid Tumor Cancers

\Multi-Center Phase I Study of Avutometinib (VS-6766), a RAF/MEK Clamp in Combination With Defactinib, a FAK Inhibitor, in Pediatric Patients With Refractory or Recurrent Solid Tumors Harboring Activating MAPK Pathway or NF2 Alterations

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 3 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether avutometinib is a safe treatment for advanced or recurrent solid tumor cancers in children and young adults. Researchers will look for the highest dose of avutometinib that is safe and cause few or mild side effects.

Conditions

• Refractory Cancer
• CNS Tumors
• CNS Tumor, Adult
• CNS Tumor, Childhood
• MAP Kinase Family Gene Mutation
• NF1
• Plexiform Neurofibroma
• Low-grade Glioma
• Optic Pathway Gliomas
• Neuroblastoma
• Primary Brain Tumor
• Solid Tumor
• Solid Tumor, Adult
• Solid Carcinoma
• Central Nervous System Tumor

Interventions

Type	Name	Description
DRUG	Avutometinib	Participants will receive oral avutometinib once daily twice a week, three weeks on/ 1week off, for a period of 28 days per cycle

Timeline

• Start date: 2023-10-20
• Primary completion: 2029-10-20
• Completion: 2029-10-20
• First posted: 2023-10-27
• Last updated: 2026-02-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study