A Study of Avutometinib for People With Solid Tumor Cancers

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06104488
Phase
PHASE1
Status
Recruiting
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Conditions

  • CNS Tumor, Adult
  • CNS Tumor, Childhood
  • CNS Tumors
  • Central Nervous System Tumor
  • Low-grade Glioma
  • MAP Kinase Family Gene Mutation
  • NF1
  • Neuroblastoma
  • Optic Pathway Gliomas
  • Plexiform Neurofibroma
  • Primary Brain Tumor
  • Refractory Cancer
  • Solid Carcinoma
  • Solid Tumor
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
3 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 20, 2023
Status verified
Feb 2026
Primary completion
Oct 20, 2029
Completion
Oct 20, 2029

Study Design

Enrollment
23 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -1
    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.
  • Experimental: Dose Level 1
    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.
  • Experimental: Dose Level 2
    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.

Primary Outcome Measure

Safety of avutometinib [ Time Frame: up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Healthcare of Atlanta (Data Collection Only)AtlantaGeorgia30322
Jason Fangusaro, MD
404-785-3240
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Sameer Farouk Sait, MD
212-639-3449

Find similar trials in Atlanta, GA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Children's Healthcare of Atlanta (Data Collection Only)· Atlanta, GAMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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