\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
Memorial Sloan Kettering Cancer Center
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
- Age range
- 3–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible to enroll in this study: * Age ≥ 3 year and ≤ 30 years at the time of informed consent. \*Patients over 18 years of age will be treated at the adult RP2D. The accrual for patients \>18 and ≤ 30 years will be limited to no more than 5 patients overall and will not participate in the dose escalation. * All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines. * Karnofsk…
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
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York