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A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 2 of 4 changed
See other at-risk trials from Daiichi Sankyo

Record History

  1. Primary endpoint(s) modified Enrollment increased: 108 → 128 participants · Primary completion moved earlier from May 15, 2030 to May 31, 2029 · Completion pushed from May 15, 2030 to Feb 28, 2031 · 4 more Show 7 more changesShow less
    • Enrollment increased: 108 → 128 participants
    • Primary completion moved earlier from May 15, 2030 to May 31, 2029
    • Completion pushed from May 15, 2030 to Feb 28, 2031
    • Trial arms changed: 3 → 4
    • Study sites: 11 to 10
    • Eligibility criteria expanded, about 113 words
    • Secondary endpoints: 9 to 10
  2. Trial sites expanded: 8 → 11 locationsv15
  3. Site details revised at 1 of 8 sitesv14
  4. Site details revised at 1 of 8 sitesv13
  5. Site details revised at 1 of 8 sitesv12
  6. Trial status changed: Active, Not Recruiting → Recruiting Site details revised at 8 of 8 sitesv11 Show 1 more changeShow less
    • Site details revised at 8 of 8 sites
  7. Primary and study completion dates: Jun 30, 2026 to May 15, 2030 Primary endpoints: 3 to 4 · Enrollment target: 78 to 108 · Eligibility criteria shortened, about 460 words · 3 morev10 Show 6 more changesShow less
    • Primary endpoints: 3 to 4
    • Enrollment target: 78 to 108
    • Eligibility criteria shortened, about 460 words
    • Secondary endpoints revised (9)
    • Study arms: 2 to 3
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  8. Trial status: Recruiting to Active, Not Recruiting Site details revised at 8 of 8 sitesv9 Show 1 more changeShow less
    • Site details revised at 8 of 8 sites
  9. Site details revised at 1 of 8 sitesv8
  10. Site details revised at 1 of 8 sitesv7
  11. Study sites: 9 to 8v6
  12. Eligibility criteria expanded, about 74 words Site details revised at 4 of 9 sitesv5 Show 1 more changeShow less
    • Site details revised at 4 of 9 sites

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 6 to 9v4
  14. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 25, 2023 to May 30, 2023 · Site details revised at 6 of 6 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of May 25, 2023 to May 30, 2023
    • Site details revised at 6 of 6 sites
  15. Start date: Apr 10, 2023 to May 25, 2023 Study sites: 1 to 6v2 Show 1 more changeShow less
    • Study sites: 1 to 6
  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.
Daiichi Sankyo
69 trials monitored
See 9 trials at risk
This study will evaluate the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.
Trial Details
NCT Number NCT05765851
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca
Conditions Advanced Solid Tumor
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov