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A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study acronym: KLK2-comPAS
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Dec 29, 2027 → Aug 18, 2028
See other at-risk trials from Johnson & Johnson

Record History

  1. Notable Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Study sites: 173 to 174 · Eligibility criteria shortened, about 7 words · Secondary endpoints: details revised at 5 of 9 entries Show 3 more changesShow less
    • Study sites: 173 to 174
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: details revised at 5 of 9 entries
  2. Notable Primary completion pushed from Dec 29, 2027 to Aug 18, 2028v14
  3. Minor Trial arms changed: 2 → 5 Study sites: 172 to 173 · Interventions: Best Supportive Care (BSC) (Drug), Pasritamig (Biological), Placebo (Other) to Best Supportive Care (BSC) (Drug), JNJ-87189401 (Biological), Pasritamig (Biological), Placebo (Other) · Eligibility criteria shortened, about 22 words · 2 morev13 Show 5 more changesShow less
    • Study sites: 172 to 173
    • Interventions: Best Supportive Care (BSC) (Drug), Pasritamig (Biological), Placebo (Other) to Best Supportive Care (BSC) (Drug), JNJ-87189401 (Biological), Pasritamig (Biological), Placebo (Other)
    • Eligibility criteria shortened, about 22 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Notable Enrollment increased: 663 → 1203 participants Completion moved earlier from Oct 18, 2028 to Aug 18, 2028 · Site details revised at 2 of 172 sitesv12 Show 2 more changesShow less
    • Completion moved earlier from Oct 18, 2028 to Aug 18, 2028
    • Site details revised at 2 of 172 sites
  5. Minor Trial sites expanded: 168 → 172 locations Completion pushed from Dec 29, 2027 to Oct 18, 2028v11 Show 1 more changeShow less
    • Completion pushed from Dec 29, 2027 to Oct 18, 2028
  6. Minor Primary and study completion moved earlier from May 30, 2028 to Dec 29, 2027 Study sites: 166 to 168v10 Show 1 more changeShow less
    • Study sites: 166 to 168
  7. Minor Trial sites expanded: 163 → 166 locationsv9
  8. Minor Study sites: 162 to 163v8
  9. Minor Study sites: 81 to 162 Eligibility criteria expanded, about 85 wordsv7 Show 1 more changeShow less
    • Eligibility criteria expanded, about 85 words

    See this version in full on ClinicalTrials.gov ↗

  10. Minor Study sites: 60 to 81v6
  11. Minor Study sites: 35 to 60v5
  12. Minor Study sites: 19 to 35v4
  13. Minor Study sites: 12 to 19v3
  14. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 7 to 12 · Start date changed from estimate of Sep 30, 2025 to Sep 2, 2025 · Eligibility criteria revised · 1 morev2 Show 4 more changesShow less
    • Study sites: 7 to 12
    • Start date changed from estimate of Sep 30, 2025 to Sep 2, 2025
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 9 of 9 entries

    See this version in full on ClinicalTrials.gov ↗

  15. Minor 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.
The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).
Trial Details
NCT Number NCT07164443
Lead Sponsor Janssen Research & Development, LLC
Conditions Metastatic Castration-resistant Prostatic Neoplasms
Enrollment 1,203 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov