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Avutometinib for Solid Tumors

Phase 1

Recruiting

Led By Sameer Farouk Sait, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age.

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 function alterations in NF1. This will be performed at the enrolling institution and central review is not required.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies avutometinib to see if it's safe & effective as a cancer treatment for children & young adults with advanced/recurring tumors.

Who is the study for?

This trial is for children and young adults aged 3 to 30 with advanced or recurrent solid tumors, including various brain and CNS tumors. Participants must have a confirmed diagnosis with specific genetic alterations or meet certain clinical criteria. They should be able to swallow capsules, have a minimum body surface area, and be past specified recovery periods from previous cancer treatments.

What is being tested?

Researchers are testing Avutometinib to determine the highest dose that's safe for treating solid tumor cancers in young patients without causing severe side effects. The study focuses on finding an effective treatment dosage for those who've had standard therapy fail them.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of drugs like Avutometinib may include fatigue, nausea, vomiting, diarrhea, skin rash, and liver function changes. Specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to care for myself, regardless of my age.

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My child's tumor has specific genetic changes in the MAP kinase pathway.

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I have a primary brain tumor with evidence of disease on MRI or positive CSF cytology.

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It has been over 84 days since my bone marrow transplant.

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I have not had major radiation therapy to my lung or abdomen in the last 42 days.

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My solid tumor can be measured or evaluated by specific medical guidelines.

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My cancer was tested using advanced genetic tests.

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I can swallow pills without any issues.

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My neuroblastoma can be seen on scans but might not have formed a tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of avutometinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Level 2Experimental Treatment1 Intervention

If 0 of 3-6 or no more than 1 of 6 evaluable participants experience a DLT, then the dose will be escalated to Dose Level 2 and the same approach will be repeated. If 2 or more DLTs are observed on Dose Level 1 in 2-6 subjects, then further enrollment to Dose Level 1 will stop, the dose will be de-escalated to Dose Level -1 and the same approach will be repeated. The MTD will be the highest dose with \<2 DLTs in 6 patients.

Group II: Dose Level 1Experimental Treatment1 Intervention

Group III: Dose Level -1Experimental Treatment1 Intervention

0 / 9Eligibility criteria met