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Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients

Study acronym: RAMP203
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 12, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Sep 2025 to Jun 2026 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 35 of 35 sitesv27 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 35 of 35 sites
  2. Study sites: 34 to 35v26
  3. Site contacts updated at 1 of 34 sitesv25
  4. Eligibility criteria expanded, about 11 wordsv24 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 2 of 34 sitesv23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 32 to 34v22
  2. Site details revised at 2 of 32 sitesv21
  3. Study sites: 19 to 32v20
  4. Secondary endpoints revised (8)v19 See this version in full on ClinicalTrials.gov ↗
  5. Secondary endpoints revised (8)v18 See this version in full on ClinicalTrials.gov ↗
  6. Enrollment target: 53 to 153 Primary endpoints revised (2) · Primary completion date: Jul 2025 to Sep 2025 · Completion date: Sep 2025 to Apr 2027 · 6 morev17 Show 9 more changesShow less
    • Primary endpoints revised (2)
    • Primary completion date: Jul 2025 to Sep 2025
    • Completion date: Sep 2025 to Apr 2027
    • Interventions: avutometinib (VS-6766) and sotorasib (Drug) to avutometinib and sotorasib (Drug), avutometinib and sotorasib and defactinib (Drug)
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (8)
    • Study arms: 3 to 6
    • Study description expanded, about 4 words
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 16 to 19v16
  8. Primary completion date: Dec 2023 to Jul 2025 Study sites: 13 to 16v15 Show 1 more changeShow less
    • Study sites: 13 to 16
  9. Study sites: 12 to 13v14
  10. Study sites: 11 to 12 Eligibility criteria revisedv13 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 10 to 11v12
  12. Site contacts updated at 1 of 10 sitesv11
  13. Study sites: 8 to 10v10
  14. Study sites: 7 to 8v9
  15. Study sites: 5 to 7v8
  16. Primary endpoints revised (2) Study sites: 4 to 5 · Interventions: VS-6766 and sotorasib (Drug) to avutometinib (VS-6766) and sotorasib (Drug) · Study description expanded, about 1 word · 1 morev7 Show 4 more changesShow less
    • Study sites: 4 to 5
    • Interventions: VS-6766 and sotorasib (Drug) to avutometinib (VS-6766) and sotorasib (Drug)
    • Study description expanded, about 1 word
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  17. Study sites: 3 to 4v6
  18. Study sites: 1 to 3 Start date changed from estimate of Mar 2022 to Apr 12, 2022v5 Show 1 more changeShow less
    • Start date changed from estimate of Mar 2022 to Apr 12, 2022
  19. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v4 Show 1 more changeShow less
    • Study sites: 0 to 1
  20. Start date: Dec 2021 to Mar 2022v3
  21. Study description revised Study title shortened, about 10 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with sotorasib with or without defactinib in patients with KRAS G12C Non-Small Cell Lung Cancer (NSCLC) in patients who have been exposed to prior G12C inhibitor and those who have not been exposed to prior G12C inhibitor.
Trial Details
NCT Number NCT05074810
Lead Sponsor Verastem, Inc.
Collaborators: Amgen
Conditions Non Small Cell Lung Cancer, KRAS Activating Mutation
Enrollment 153 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov