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Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Secondary endpoints: 4 to 11v19 Show 1 more changeShow less
    • Secondary endpoints: 4 to 11

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  2. Primary endpoints: 8 to 10 Enrollment target: 341 to 336 · Study sites: 10 to 15 · Primary completion date: Dec 31, 2026 to Jan 29, 2027 · 4 morev18 Show 7 more changesShow less
    • Enrollment target: 341 to 336
    • Study sites: 10 to 15
    • Primary completion date: Dec 31, 2026 to Jan 29, 2027
    • Completion date: Mar 31, 2027 to Jun 15, 2027
    • Eligibility criteria expanded, about 135 words
    • Secondary endpoints: 7 to 4
    • Study arms: 9 to 8

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Oct 31, 2024 to Dec 31, 2026 Enrollment target: 278 to 341 · Study sites: 14 to 10 · Completion date: May 31, 2025 to Mar 31, 2027 · 1 morev17 Show 4 more changesShow less
    • Enrollment target: 278 to 341
    • Study sites: 14 to 10
    • Completion date: May 31, 2025 to Mar 31, 2027
    • Eligibility criteria expanded, about 74 words

    See this version in full on ClinicalTrials.gov ↗

  4. Site details revised at 1 of 14 sitesv16
  5. Primary completion date: Dec 31, 2023 to Oct 31, 2024 Primary endpoints: 6 to 8 · Enrollment target: 254 to 278 · Completion date: Jul 31, 2024 to May 31, 2025 · 2 morev15 Show 5 more changesShow less
    • Primary endpoints: 6 to 8
    • Enrollment target: 254 to 278
    • Completion date: Jul 31, 2024 to May 31, 2025
    • Site details revised at 4 of 14 sites
    • Study arms: 7 to 9

    See this version in full on ClinicalTrials.gov ↗

Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Dec 31, 2022 to Dec 31, 2023 Completion date: Dec 31, 2023 to Jul 31, 2024 · Site contacts updated at 1 of 14 sitesv14 Show 2 more changesShow less
    • Completion date: Dec 31, 2023 to Jul 31, 2024
    • Site contacts updated at 1 of 14 sites
  2. Study sites: 12 to 14v13
  3. Primary completion date: Dec 15, 2021 to Dec 31, 2022 Primary endpoints: 4 to 6 · Study sites: 9 to 12 · Completion date: Apr 30, 2023 to Dec 31, 2023 · 2 morev12 Show 5 more changesShow less
    • Primary endpoints: 4 to 6
    • Study sites: 9 to 12
    • Completion date: Apr 30, 2023 to Dec 31, 2023
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoints: 5 to 4 Enrollment target: 217 to 254 · Interventions: Binimetinib (Drug), IDE196 (Drug) to Binimetinib (Drug), Crizotinib (Drug), IDE196 (Drug) · Eligibility criteria expanded, about 120 words · 2 morev11 Show 5 more changesShow less
    • Enrollment target: 217 to 254
    • Interventions: Binimetinib (Drug), IDE196 (Drug) to Binimetinib (Drug), Crizotinib (Drug), IDE196 (Drug)
    • Eligibility criteria expanded, about 120 words
    • Secondary endpoints: 5 to 6
    • Study arms: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 8 to 9v10
  6. Study sites: 6 to 8v9
  7. Primary endpoints revised (5) Enrollment target: 166 to 217 · Study sites: 5 to 6 · Interventions: IDE196 (Drug) to Binimetinib (Drug), IDE196 (Drug) · 3 morev8 Show 6 more changesShow less
    • Enrollment target: 166 to 217
    • Study sites: 5 to 6
    • Interventions: IDE196 (Drug) to Binimetinib (Drug), IDE196 (Drug)
    • Eligibility criteria expanded, about 77 words
    • Secondary endpoints: 3 to 5
    • Study arms: 2 to 5

    See this version in full on ClinicalTrials.gov ↗

  8. Re-verified, no change to tracked fieldsv7
  9. Study sites: 4 to 5v6
  10. Study sites: 1 to 4 Start date changed from estimate of Jul 31, 2019 to Jun 28, 2019 · Eligibility criteria expanded, about 4 wordsv5 Show 2 more changesShow less
    • Start date changed from estimate of Jul 31, 2019 to Jun 28, 2019
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  11. Site contact updatedv4
  12. Trial status: Not Yet Recruiting to Recruiting Start date: Jun 1, 2019 to Jul 31, 2019 · Study sites: 0 to 1v3 Show 2 more changesShow less
    • Start date: Jun 1, 2019 to Jul 31, 2019
    • Study sites: 0 to 1
  13. Study title shortened, about 3 wordsv2 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 is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study. Crizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity. As of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.
Trial Details
NCT Number NCT03947385
Lead Sponsor IDEAYA Biosciences
Conditions Metastatic Uveal Melanoma, Cutaneous Melanoma, Colorectal Cancer, Other Solid Tumors
Enrollment 336 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov