RecruitingPhase 1NCT06104488

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

23 participants

Start Date

Oct 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called avutometinib in children and young adults (ages 3–30) with solid tumors — particularly brain tumors and tumors driven by specific genetic changes in a pathway called the MAP kinase (RAS/MAPK) pathway, which includes mutations in genes like BRAF, KRAS, NRAS, and NF1. **You may be eligible if...** - You are between 3 and 30 years old - You have a confirmed tumor with a MAP kinase pathway mutation (e.g., BRAF, KRAS, NF1, PTPN11, SOS1/2) - You have neurofibromatosis type 1 (NF1) with inoperable growing tumors (plexiform neurofibromas or low-grade glioma) - You have a recurring or worsening optic pathway glioma (a brain tumor affecting vision) - You have neurofibromatosis type 2 / schwannomatosis - You are well enough to attend school or carry out age-appropriate activities (Karnofsky/Lansky ≥ 50) **You may NOT be eligible if...** - You have active or uncontrolled infections - You have received certain prior treatments that conflict with this study - Your organ function is inadequate - You cannot swallow the medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAvutometinib

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


Locations(2)

Children's Healthcare of Atlanta (Data Collection Only)

Atlanta, Georgia, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06104488


Related Trials