Actively Recruiting
A Study of Avutometinib for People With Solid Tumor Cancers
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-25
23
Participants Needed
2
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Avutometinib for People With Solid Tumor Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 to 30 years at time of informed consent
- Written informed consent signed by patient and/or parent or legal representative; assent as appropriate
- Karnofsky score 50% if older than 16 years, Lansky score 50 if 16 years or younger
- Histologically confirmed pediatric tumor with activating MAP kinase pathway alterations or molecularly confirmed NF1, NF2, or recurrent optic pathway gliomas with progression
- Measurable or evaluable disease per RECIST or MRI criteria depending on tumor type
- Tumor refractory or recurrent after standard therapy, with some exceptions
- Body surface area 0.8 m2
- Able to swallow intact capsules
- May have prior monotherapy treatment with RAF or MEK inhibitors
- Fully recovered from acute toxic effects of prior therapies with minimum waiting periods met
- Adequate liver, kidney, and hematologic function within specified limits
- Creatine phosphokinase 2.5 times upper limit of normal
- Recovery from prior treatment toxicities to Grade 1 or less except for specified exceptions
- Agree to use effective birth control if of reproductive potential
You will not qualify if you...
- History of rhabdomyolysis
- Certain active ocular disorders including glaucoma, retinal vein occlusion, corneal diseases
- Hypersensitivity to inactive ingredients of the study drug
- Active diarrhea requiring medication within 7 days
- Significant cardiac disease or risk factors including heart failure, low ejection fraction, prolonged QTc interval
- Active hepatitis B, hepatitis C, or HIV infection requiring therapy
- Recent exposure to strong CYP3A4 inhibitors or inducers including certain foods, drugs, and herbal supplements
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Children's Healthcare of Atlanta (Data Collection Only)
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
Research Team
S
Sameer Farouk Sait, MD
CONTACT
J
Julia Glade Bender, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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