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A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer

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

Record History

  1. Primary endpoint(s) modified Primary and study completion pushed from May 2029 to Jul 2029 · Enrollment increased: 208 → 262 participants · Trial sites reduced: 39 → 13 locations · 4 morev6 Show 7 more changesShow less
    • Primary and study completion pushed from May 2029 to Jul 2029
    • Enrollment increased: 208 → 262 participants
    • Trial sites reduced: 39 → 13 locations
    • Trial arms changed: 6 → 9
    • Interventions: IDE161 (Drug), IDE849 (Drug), durvalumab (Drug) to Carboplatin (Drug), IDE161 (Drug), IDE849 (Drug), durvalumab (Drug)
    • Eligibility criteria expanded, about 180 words
    • Secondary endpoints revised (6)

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 27 to 39v5
  3. Enrollment target: 90 to 208 Primary endpoints: 4 to 6 · Study sites: 10 to 27 · Interventions: IDE849 (Drug) to IDE161 (Drug), IDE849 (Drug), durvalumab (Drug) · 4 morev4 Show 7 more changesShow less
    • Primary endpoints: 4 to 6
    • Study sites: 10 to 27
    • Interventions: IDE849 (Drug) to IDE161 (Drug), IDE849 (Drug), durvalumab (Drug)
    • Eligibility criteria expanded, about 294 words
    • Secondary endpoints: 4 to 6
    • Study description expanded, about 64 words
    • Study arms: 2 to 6

    See this version in full on ClinicalTrials.gov ↗

  4. Start date changed from estimate of Sep 2025 to Oct 14, 2025 Site details revised at 1 of 10 sitesv3 Show 1 more changeShow less
    • Site details revised at 1 of 10 sites
  5. Study sites: 9 to 10v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.
Trial Details
NCT Number NCT07174583
Lead Sponsor IDEAYA Biosciences
Conditions Small-cell Lung Cancer, Neuroendocrine Carcinomas, Solid Tumor Show to Express DLL3
Enrollment 262 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov