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A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Apr 1, 2031 → Oct 1, 2031
See other at-risk trials from Merck (MSD)

Record History

  1. Primary and study completion pushed from Apr 1, 2031 to Oct 1, 2031
  2. Study sites revised (82)
  3. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Eligibility criteria expanded, about 20 words · Secondary endpoints: details revised at 7 of 7 entries · Site details revised at 6 of 82 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised at 6 of 82 sites
  4. Site details revised at 1 of 82 sitesv43
  5. Study sites: 81 to 82v42
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 82 to 81 Interventions: Abiraterone (Drug), Docetaxel (Drug), Enzalutamide (Drug), Ifinatamab Deruxtecan (Drug), MK-5684 (Drug), Rescue Medication (Drug) to Abiraterone (Drug), Docetaxel (Drug), Enzalutamide (Drug), Ifinatamab Deruxtecan (Drug), Opevesostat (Drug), Rescue Medication (Drug) · Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 3 of 7 entriesv41 Show 3 more changesShow less
    • Interventions: Abiraterone (Drug), Docetaxel (Drug), Enzalutamide (Drug), Ifinatamab Deruxtecan (Drug), MK-5684 (Drug), Rescue Medication (Drug) to Abiraterone (Drug), Docetaxel (Drug), Enzalutamide (Drug), Ifinatamab Deruxtecan (Drug), Opevesostat (Drug), Rescue Medication (Drug)
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 3 of 7 entries

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites revised (82)v40 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 80 to 82v39
  4. Study sites revised (80)v38 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 79 to 80v37
  6. Study sites: 78 to 79v36
  7. Study sites: 76 to 78v35
  8. Study sites: 75 to 76v34
  9. Study sites: 74 to 75v33
  10. Study sites: 72 to 74v32
  1. Trial sites expanded: 68 → 72 locationsv31
  2. Primary completion date: Feb 18, 2030 to Apr 1, 2031 Completion date: Feb 24, 2030 to Apr 1, 2031v30 Show 1 more changeShow less
    • Completion date: Feb 24, 2030 to Apr 1, 2031
  3. Study sites: 67 to 68v29
  4. Study sites: 64 to 67v28
  5. Re-verified, no change to tracked fieldsv27
  6. Study sites: 63 to 64v26
  7. Study sites: 62 to 63v25
  8. Study sites: 60 to 62v24
  9. Study sites: 58 to 60v23
  10. Study sites: 56 to 58v22
  11. Study sites: 55 to 56v21
  12. Study sites: 54 to 55v20
  13. Study sites: 51 to 54v19
  14. Interventions: Abiraterone (Drug), Docetaxel (Drug), Enzalutamide (Drug), Ifinatamab Deruxtecan (Drug), MK-5684 (Drug) to Abiraterone (Drug), Docetaxel (Drug), Enzalutamide (Drug), Ifinatamab Deruxtecan (Drug), MK-5684 (Drug), Rescue Medication (Drug) Study description revisedv18 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 50 to 51v17
  16. Study sites: 48 to 50v16
  17. Study sites: 47 to 48v15
  18. Study sites: 45 to 47v14
  19. Study sites: 41 to 45v13
  20. Study sites: 35 to 41v12
  21. Study sites: 32 to 35v11
  22. Study sites: 29 to 32v10
  23. Study sites: 24 to 29v9
  24. Study sites: 21 to 24v8
  25. Study sites: 12 to 21v7
  26. Study sites: 7 to 12v6
  27. Study sites: 6 to 7 Start date: Jun 25, 2025 to Jul 3, 2025v5 Show 1 more changeShow less
    • Start date: Jun 25, 2025 to Jul 3, 2025
  28. Study sites: 2 to 6v4
  29. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Completion date: Feb 18, 2030 to Feb 24, 2030 · Start date changed from estimate of Jun 17, 2025 to Jun 25, 2025v3 Show 3 more changesShow less
    • Study sites: 0 to 2
    • Completion date: Feb 18, 2030 to Feb 24, 2030
    • Start date changed from estimate of Jun 17, 2025 to Jun 25, 2025
  30. Re-verified, no change to tracked fieldsv2
  31. 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.
Merck (MSD)
407 trials monitored
See 29 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: * The safety of the study treatment and if people tolerate it. * A safe dose level of I-DXd that can be used with other treatments. * Participant levels of prostate specific antigen (PSA) during treatment.
Trial Details
NCT Number NCT06863272
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions Castration-Resistant Prostatic Cancer, Metastasis
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov