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Recruiting Phase 1 NCT06104488

A Study of Avutometinib for People With Solid Tumor Cancers

Trial Parameters

Condition Refractory Cancer
Sponsor Memorial Sloan Kettering Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 23
Sex ALL
Min Age 3 Years
Max Age 30 Years
Start Date 2023-10-20
Completion 2029-10-20
Interventions
Avutometinib

Brief 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 Criteria

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. * Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age. * Participants must have one of the following: 1. Histologically confirmed diagnosis of a pediatric tumor including CNS tumors with activating MAP kinase pathway alterations including but not limited to BRAF/ARAF/CRAF fusions or mutations, KRAS/NRAS/HRAS alterations, PTPN11 or SOS1/2 mutations and/or loss of func

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