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Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion moved earlier from Dec 31, 2026 to Jun 23, 2026v40
  2. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 822 to confirmed 731 · Study sites: 228 to 222v39 Show 2 more changesShow less
    • Enrollment target: estimated 822 to confirmed 731
    • Study sites: 228 to 222
  3. Notable Primary completion date: Jul 14, 2025 to Dec 31, 2026 Completion date: Jan 16, 2026 to Dec 31, 2026 · Site contacts updated at 1 of 228 sitesv38 Show 2 more changesShow less
    • Completion date: Jan 16, 2026 to Dec 31, 2026
    • Site contacts updated at 1 of 228 sites
  4. Minor Study sites: 214 to 228v37
  5. Minor Study sites: 107 to 214 Primary completion date: Jul 31, 2025 to Jul 14, 2025 · Completion date: Jan 31, 2026 to Jan 16, 2026 · Start date: Dec 26, 2018 to Jan 15, 2019v36 Show 3 more changesShow less
    • Primary completion date: Jul 31, 2025 to Jul 14, 2025
    • Completion date: Jan 31, 2026 to Jan 16, 2026
    • Start date: Dec 26, 2018 to Jan 15, 2019
Show 34 earlier versionsHide 34 earlier versions
  1. Minor Study sites: 98 to 107 Primary completion date: Jul 2025 to Jul 31, 2025 · Completion date: Jan 2026 to Jan 31, 2026v35 Show 2 more changesShow less
    • Primary completion date: Jul 2025 to Jul 31, 2025
    • Completion date: Jan 2026 to Jan 31, 2026
  2. Minor Re-verified, no change to tracked fieldsv34
  3. Notable Primary completion date: Dec 2023 to Jul 2025 Completion date: Sep 2024 to Jan 2026 · Start date: Jan 15, 2019 to Dec 26, 2018v33 Show 2 more changesShow less
    • Completion date: Sep 2024 to Jan 2026
    • Start date: Jan 15, 2019 to Dec 26, 2018
  4. Minor Study sites revised (98)v32 See this version in full on ClinicalTrials.gov ↗
  5. Notable Primary completion date: Dec 2022 to Dec 2023 Enrollment target: 740 to 822 · Study sites: 81 to 98 · Completion date: Sep 2023 to Sep 2024v31 Show 3 more changesShow less
    • Enrollment target: 740 to 822
    • Study sites: 81 to 98
    • Completion date: Sep 2023 to Sep 2024
  6. Notable Primary completion date: Mar 2022 to Dec 2022 Enrollment target: 565 to 740 · Study sites: 75 to 81 · Completion date: Dec 2022 to Sep 2023 · 1 morev30 Show 4 more changesShow less
    • Enrollment target: 565 to 740
    • Study sites: 75 to 81
    • Completion date: Dec 2022 to Sep 2023
    • Study arms: 6 to 9
  7. Minor Eligibility criteria expanded, about 7 wordsv29 See this version in full on ClinicalTrials.gov ↗
  8. Minor Enrollment target: 391 to 565 Study sites: 69 to 75 · Primary completion date: Dec 2021 to Mar 2022 · Completion date: Sep 2022 to Dec 2022 · 1 morev28 Show 4 more changesShow less
    • Study sites: 69 to 75
    • Primary completion date: Dec 2021 to Mar 2022
    • Completion date: Sep 2022 to Dec 2022
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  9. Minor Study sites: 68 to 69v27
  10. Minor Study sites: 65 to 68v26
  11. Notable Primary completion date: Dec 2020 to Dec 2021 Completion date: Sep 2021 to Sep 2022v25 Show 1 more changeShow less
    • Completion date: Sep 2021 to Sep 2022
  12. Minor Study sites: 63 to 65v24
  13. Minor Study sites: 56 to 63v23
  14. Minor Study sites: 47 to 56v22
  15. Minor Study sites: 43 to 47v21
  16. Minor Study sites: 41 to 43v20
  17. Minor Study sites: 40 to 41v19
  18. Minor Study sites: 39 to 40v18
  19. Minor Study sites: 35 to 39v17
  20. Minor Study sites: 34 to 35v16
  21. Minor Study sites: 28 to 34v15
  22. Minor Study sites: 27 to 28v14
  23. Minor Eligibility criteria shortened, about 3 wordsv13 See this version in full on ClinicalTrials.gov ↗
  24. Minor Study sites: 25 to 27v12
  25. Notable Enrollment target: 200 to 391 Primary completion date: Apr 2020 to Dec 2020 · Primary endpoints: 2 to 3 · Study sites: 22 to 25 · 5 morev11 Show 8 more changesShow less
    • Primary completion date: Apr 2020 to Dec 2020
    • Primary endpoints: 2 to 3
    • Study sites: 22 to 25
    • Completion date: Apr 2020 to Sep 2021
    • Interventions: MRTX849 (Drug) to Afatinib (Drug), Cetuximab (Drug), MRTX849 (Drug), Pembrolizumab (Drug)
    • Secondary endpoints: 2 to 4
    • Study arms: 3 to 6
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  26. Minor Study sites: 13 to 22v10
  27. Minor Re-verified, no change to tracked fieldsv9
  28. Minor Study sites: 12 to 13v8
  29. Minor Study sites: 11 to 12 Study description expanded, about 3 words · Study title expanded, about 4 wordsv7 Show 2 more changesShow less
    • Study description expanded, about 3 words
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  30. Minor Study sites: 9 to 11v6
  31. Minor Study sites: 6 to 9v5
  32. Minor Study sites: 3 to 6v4
  33. Minor Study sites: 2 to 3 Start date changed from estimate of Jan 2019 to Jan 15, 2019v3 Show 1 more changeShow less
    • Start date changed from estimate of Jan 2019 to Jan 15, 2019
  34. Minor Study sites: 1 to 2v2
  1. Minor 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 evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
Trial Details
NCT Number NCT03785249
Lead Sponsor Mirati Therapeutics Inc.
Conditions Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease
Enrollment 731 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov