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Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

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

Record History

  1. Primary endpoints revised (5) Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 180 to confirmed 169 · Study sites: 39 to 37 · 6 morev19 Show 9 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 180 to confirmed 169
    • Study sites: 39 to 37
    • Primary completion date: Dec 31, 2026 to Jan 7, 2027
    • Completion date: Mar 30, 2027 to Feb 4, 2027
    • Interventions: Docetaxel (Drug), IDE397 (Drug), Paclitaxel (Drug), Sacituzumab govitecan (Drug) to IDE397 (Drug), Sacituzumab govitecan (Drug)
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints revised (4)
    • Study arms: 6 to 4

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 38 to 39v18
  3. Site details revised at 1 of 38 sitesv17
  4. Site details revised at 2 of 38 sitesv16
  5. Primary completion date: Dec 31, 2023 to Dec 31, 2026 Primary endpoints revised (5) · Enrollment target: 130 to 180 · Study sites: 35 to 38 · 5 morev15 Show 8 more changesShow less
    • Primary endpoints revised (5)
    • Enrollment target: 130 to 180
    • Study sites: 35 to 38
    • Completion date: Jun 30, 2024 to Mar 30, 2027
    • Interventions: Docetaxel (Drug), IDE397 (Drug), Paclitaxel (Drug) to Docetaxel (Drug), IDE397 (Drug), Paclitaxel (Drug), Sacituzumab govitecan (Drug)
    • Secondary endpoints revised (4)
    • Study arms: 4 to 6
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

Show 13 earlier versionsHide 13 earlier versions
  1. Enrollment target: 382 to 130 Primary endpoints revised (5) · Study sites: 11 to 35 · Interventions: Docetaxel (Drug), Gemcitabine (Drug), IDE397 (Drug), Nab paclitaxel (Drug), Paclitaxel (Drug), Pemetrexed (Drug) to Docetaxel (Drug), IDE397 (Drug), Paclitaxel (Drug) · 3 morev14 Show 6 more changesShow less
    • Primary endpoints revised (5)
    • Study sites: 11 to 35
    • Interventions: Docetaxel (Drug), Gemcitabine (Drug), IDE397 (Drug), Nab paclitaxel (Drug), Paclitaxel (Drug), Pemetrexed (Drug) to Docetaxel (Drug), IDE397 (Drug), Paclitaxel (Drug)
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 5 to 4
    • Study arms: 8 to 4

    See this version in full on ClinicalTrials.gov ↗

  2. Site contacts updated at 2 of 11 sitesv13
  3. Enrollment target: 40 to 382 Primary completion date: Dec 31, 2022 to Dec 31, 2023 · Primary endpoints: 2 to 5 · Completion date: Dec 31, 2024 to Jun 30, 2024 · 5 morev12 Show 8 more changesShow less
    • Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Primary endpoints: 2 to 5
    • Completion date: Dec 31, 2024 to Jun 30, 2024
    • Interventions: IDE397 (Drug) to Docetaxel (Drug), Gemcitabine (Drug), IDE397 (Drug), Nab paclitaxel (Drug), Paclitaxel (Drug), Pemetrexed (Drug)
    • Eligibility criteria shortened, about 165 words
    • Secondary endpoints: 3 to 5
    • Site contacts updated at 1 of 11 sites
    • Study arms: 1 to 8

    See this version in full on ClinicalTrials.gov ↗

  4. Site details revised at 1 of 11 sitesv11
  5. Site details revised at 2 of 11 sitesv10
  6. Study sites: 8 to 11v9
  7. Study sites: 7 to 8v8
  8. Study sites: 6 to 7v7
  9. Study sites: 4 to 6v6
  10. Site details revised at 1 of 4 sitesv5
  11. Study sites: 3 to 4v4
  12. Study sites: 2 to 3 Start date changed from estimate of Mar 15, 2021 to Apr 14, 2021v3 Show 1 more changeShow less
    • Start date changed from estimate of Mar 15, 2021 to Apr 14, 2021
  13. Study sites: 1 to 2v2
  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 is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).
Trial Details
NCT Number NCT04794699
Lead Sponsor IDEAYA Biosciences
Conditions Solid Tumor
Enrollment 169 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov