Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Oct 30, 2026 → Jun 25, 2027
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 30, 2026 to Jun 25, 2027
    • Study completion pushed from Oct 31, 2026 to Jun 25, 2027
    • Study sites revised (9)
    • Eligibility criteria expanded, about 5 words
  2. Primary completion date: Mar 30, 2026 to Oct 30, 2026
    • Study completion date: Mar 31, 2026 to Oct 31, 2026
    • Site details revised at 2 of 9 sites
    v32
  3. Primary completion date: Dec 31, 2025 to Mar 30, 2026
    • Study completion date: Dec 31, 2025 to Mar 31, 2026
    • Site details revised at 1 of 9 sites
    v31
  4. Primary and study completion dates: Sep 30, 2025 to Dec 31, 2025v30
  5. Re-verified, no change to tracked fieldsv29
Show 27 earlier versionsHide 27 earlier versions
  1. Primary completion date: May 29, 2025 to Sep 30, 2025
    • Study completion date: May 30, 2025 to Sep 30, 2025
    • Site details revised at 1 of 9 sites
    v28
  2. Enrollment target: 99 to 98
    • Primary completion date: Feb 28, 2025 to May 29, 2025
    • Study completion date: Feb 28, 2025 to May 30, 2025
    • Site details revised at 1 of 9 sites
    v27
  3. Enrollment target: 98 to 99
    • Primary completion date: Dec 20, 2024 to Feb 28, 2025
    v26
  4. Primary completion date: May 16, 2025 to Dec 20, 2024
    • Study completion date: May 16, 2025 to Feb 28, 2025
    • Study sites revised (9)
    v25
  5. Primary and study completion dates: Dec 20, 2024 to May 16, 2025
    • Site details revised at 1 of 9 sites
    v24
  6. Primary and study completion dates: Sep 12, 2024 to Dec 20, 2024
    • Study sites revised (9)
    v23
  7. Primary and study completion dates: May 16, 2025 to Sep 12, 2024v22
  8. Primary and study completion dates: Apr 29, 2024 to May 16, 2025v21
  9. Enrollment target: 99 to 98v20
  10. Primary and study completion dates: Mar 29, 2024 to Apr 29, 2024v19
  11. Primary and study completion dates: May 16, 2025 to Mar 29, 2024v18
  12. Primary and study completion dates: Mar 29, 2024 to May 16, 2025v17
  13. Primary and study completion dates: May 16, 2025 to Mar 29, 2024v16
  14. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 380 to confirmed 99
    • Site details revised at 9 of 9 sites
    v15
  15. Primary and study completion dates: Apr 15, 2024 to May 16, 2025
    • Site contacts updated at 3 of 9 sites
    v14
  16. Primary and study completion dates: Apr 14, 2023 to Apr 15, 2024
    • Site contacts updated at 2 of 9 sites
    v13
  17. Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 9 to 8
    • Site contacts updated at 1 of 9 sites
    v12
  18. Re-verified, no change to tracked fieldsv11
  19. Study sites: 7 to 9v10
  20. Study sites: 6 to 7v9
  21. Enrollment target: 320 to 380v8
  22. Re-verified, no change to tracked fieldsv7
  23. Study sites: 5 to 6
    • Primary and study completion dates: Nov 28, 2022 to Apr 14, 2023
    v6
  24. Study sites: 3 to 5v5
  25. Re-verified, no change to tracked fieldsv4
  26. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Apr 18, 2019 to May 7, 2019
    v3
  27. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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.
Novartis
556 trials monitored
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Breast Cancer
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Colorectal Cancer
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and 4 more diseases
This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1/PD-L1 therapy, or subjects with NPC. After the determination of the MTD/RD for a particular treatment arm, dose expansion will further assess safety, tolerability, PK/PD, and anti-tumor activity of each regimen at the MTD/RD.
Trial Details
NCT Number NCT03891953
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Carcinoma, Non-Small-Cell Lung, Melanoma, Nasopharyngeal Carcinoma, Microsatellite Stable Colorectal Cancer, Triple Negative Breast Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Melanoma, Nasopharyngeal Carcinoma, Triple Negative Breast Neoplasms
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov