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A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

Study acronym: DAWN-303
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 46 of 228 sites
  2. Study sites: 229 to 228
  3. Trial sites expanded: 219 → 229 locations Interventions: INCB161734 (Drug), Investigator's choice of chemotherapy (Drug), Placebo (Drug) to INCB161734 (Drug), Investigator's choice of chemotherapy (Drug), Placebo (Drug) · Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 3 of 11 entries Show 3 more changesShow less
    • Interventions: INCB161734 (Drug), Investigator's choice of chemotherapy (Drug), Placebo (Drug) to INCB161734 (Drug), Investigator's choice of chemotherapy (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 11 entries
  4. Trial sites expanded: 215 → 219 locationsv13
  5. Study sites: 214 to 215v12
  6. Trial sites reduced: 218 → 214 locationsv11
  7. Study sites: 217 to 218v10
  8. Study sites: 215 to 217v9
  9. Collaborators expanded, about 3 wordsv8 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 213 to 215v7
  11. Study sites: 212 to 213v6
  12. Site details revised at 5 of 212 sitesv5
  13. Site details revised at 2 of 212 sitesv4
  14. Study sites revised (212)v3 See this version in full on ClinicalTrials.gov ↗
  15. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 212 · Start date changed from estimate of Apr 3, 2026 to Apr 9, 2026v2 Show 2 more changesShow less
    • Study sites: 0 to 212
    • Start date changed from estimate of Apr 3, 2026 to Apr 9, 2026
  16. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Incyte
94 trials monitored
See 9 trials at risk
The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
Trial Details
NCT Number NCT07522073
Lead Sponsor Incyte Corporation
Collaborators: Qiagen Manchester Ltd
Conditions Solid Tumors
Enrollment 588 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov