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Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Trial sites reduced: 28 → 23 locations · Enrollment target: estimated 250 to confirmed 247 · Eligibility criteria expanded, about 13 words · 2 more Show 5 more changesShow less
    • Trial sites reduced: 28 → 23 locations
    • Enrollment target: estimated 250 to confirmed 247
    • Eligibility criteria expanded, about 13 words
    • Collaborators: details revised at 1 of 1 entry
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 25 → 28 locations Site details revised at 2 of 28 sitesv48 Show 1 more changeShow less
    • Site details revised at 2 of 28 sites
  3. Study sites: 25 to 28v47
  4. Site details revised at 5 of 25 sitesv46
  5. Primary completion date: Dec 1, 2025 to Apr 30, 2027 Completion date: Mar 1, 2027 to Oct 31, 2029v45 Show 1 more changeShow less
    • Completion date: Mar 1, 2027 to Oct 31, 2029
Show 43 earlier versionsHide 43 earlier versions
  1. Eligibility criteria expanded, about 42 wordsv44 See this version in full on ClinicalTrials.gov ↗
  2. Primary completion date: Dec 1, 2024 to Dec 1, 2025 Study sites: 23 to 25v43 Show 1 more changeShow less
    • Study sites: 23 to 25
  3. Re-verified, no change to tracked fieldsv42
  4. Study sites: 22 to 23v41
  5. Lead sponsor: Daiichi Sankyo Co., Ltd. to Daiichi Sankyo Eligibility criteria expanded, about 32 words · Collaborators expanded, about 5 words · Study title expanded, about 1 wordv40 Show 3 more changesShow less
    • Eligibility criteria expanded, about 32 words
    • Collaborators expanded, about 5 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Enrollment target: 195 to 250 Study title expanded, about 2 wordsv39 Show 1 more changeShow less
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  7. Primary completion date: Dec 2024 to Dec 1, 2024 Completion date: Mar 2027 to Mar 1, 2027 · Site details revised at 1 of 22 sitesv38 Show 2 more changesShow less
    • Completion date: Mar 2027 to Mar 1, 2027
    • Site details revised at 1 of 22 sites
  8. Primary completion date: Oct 31, 2023 to Dec 2024 Completion date: Oct 31, 2023 to Mar 2027v37 Show 1 more changeShow less
    • Completion date: Oct 31, 2023 to Mar 2027
  9. 3 versions Re-verified since May 22, 2023, no change to tracked fieldsv34-v36
  10. Primary completion date: Mar 1, 2023 to Oct 31, 2023 Primary endpoints revised (3) · Completion date: Dec 1, 2023 to Oct 31, 2023 · Interventions: DS-7300a (Drug) to Ifinatamab deruxtecan (I-DXd) (Drug) · 1 morev33 Show 4 more changesShow less
    • Primary endpoints revised (3)
    • Completion date: Dec 1, 2023 to Oct 31, 2023
    • Interventions: DS-7300a (Drug) to Ifinatamab deruxtecan (I-DXd) (Drug)
    • Eligibility criteria shortened, about 56 words

    See this version in full on ClinicalTrials.gov ↗

  11. Site details revised at 2 of 22 sitesv32
  12. Re-verified, no change to tracked fieldsv31
  13. Site details revised at 1 of 22 sitesv30
  14. Enrollment target: 205 to 195 Site details revised at 1 of 22 sitesv29 Show 1 more changeShow less
    • Site details revised at 1 of 22 sites
  15. Site details revised at 1 of 22 sitesv28
  16. Enrollment target: 180 to 205 Completion date: Oct 1, 2023 to Dec 1, 2023 · Site contacts updated at 6 of 22 sitesv27 Show 2 more changesShow less
    • Completion date: Oct 1, 2023 to Dec 1, 2023
    • Site contacts updated at 6 of 22 sites
  17. Study sites: 20 to 22v26
  18. Study sites: 19 to 20v25
  19. Enrollment target: 160 to 180 Eligibility criteria expanded, about 32 wordsv24 Show 1 more changeShow less
    • Eligibility criteria expanded, about 32 words

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 18 to 19v23
  21. Study sites: 16 to 18v22
  22. Site details revised at 3 of 16 sitesv21
  23. Site details revised at 2 of 16 sitesv20
  24. Study sites: 12 to 16v19
  25. Site details revised at 1 of 12 sitesv18
  26. Re-verified, no change to tracked fieldsv17
  27. Site contacts updated at 1 of 12 sitesv16
  28. Re-verified, no change to tracked fieldsv15
  29. Primary completion date: Jan 31, 2023 to Mar 1, 2023 Completion date: Jan 31, 2023 to Oct 1, 2023 · Start date: Oct 17, 2019 to Nov 3, 2019v14 Show 2 more changesShow less
    • Completion date: Jan 31, 2023 to Oct 1, 2023
    • Start date: Oct 17, 2019 to Nov 3, 2019
  30. Study sites: 6 to 12v13
  31. 3 versions Re-verified since Jul 1, 2020, no change to tracked fieldsv10-v12
  32. Site details revised at 1 of 6 sitesv9
  33. 2 versions Re-verified since May 7, 2020, no change to tracked fieldsv7-v8
  34. Site details revised at 1 of 6 sitesv6
  35. Site details revised at 1 of 6 sitesv5
  36. Study sites: 5 to 6v4
  37. Re-verified, no change to tracked fieldsv3
  38. Study sites: 3 to 5v2
  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.
Daiichi Sankyo
69 trials monitored
See 9 trials at risk
This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. The primary purpose of the parts are: * Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd). * Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent. This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: * they withdraw * their disease gets worse * they experience unacceptable side effects.
Trial Details
NCT Number NCT04145622
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Advanced Solid Tumor, Malignant Solid Tumor
Enrollment 247 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov