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NCT06104488

A Study of Avutometinib for People With Solid Tumor Cancers

StatusCompleted
PhasePhase 1
Primary completion
Track this trial

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Record History

All 7 versions: 5 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Primary completion date changed from estimate of Oct 20, 2029 to Nov 3, 2026
    • Eligibility criteria expanded, about 37 words
    • Site details revised at 1 of 2 sites
  2. Enrollment reduced: 23 → 3 participants
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v6
  3. Enrollment target: 24 to 23
    • Eligibility criteria expanded, about 156 words
    v5
  4. Site details revised at 1 of 2 sitesv3
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Safety of avutometinib
Timeframe: up to 12 months

Arms and interventions

Dose Level -1Experimental

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.

Dose Level 1Experimental

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.

Dose Level 2Experimental

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.

Drugs: Avutometinib

Sites

2 sites in 1 country