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Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later across 2 updates Apr 2028 → Aug 17, 2028
See other at-risk trials from Johnson & Johnson

Record History

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Primary and study completion pushed from Jul 11, 2028 to Aug 17, 2028 · Eligibility criteria revised Show 2 more changesShow less
    • Primary and study completion pushed from Jul 11, 2028 to Aug 17, 2028
    • Eligibility criteria revised
  2. Re-verified, no change to tracked fieldsv9
  3. Primary completion pushed from Apr 2028 to Jul 11, 2028 Trial sites expanded: 12 → 18 locations · Completion moved earlier from Apr 2030 to Jul 11, 2028 · Start date: Feb 20, 2025 to Feb 6, 2025 · 3 morev8 Show 6 more changesShow less
    • Trial sites expanded: 12 → 18 locations
    • Completion moved earlier from Apr 2030 to Jul 11, 2028
    • Start date: Feb 20, 2025 to Feb 6, 2025
    • Interventions: HLD-0915 Hard Capsule (Drug), HLD-0915 Soft Capsule (Drug), HLD-0915 Tablet (Drug) to JNJ-101556143 Formulation 1 (Drug), JNJ-101556143 Formulation 2 (Drug), JNJ-101556143 Formulation 3 (Drug)
    • Study description shortened, about 170 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Changed Sponsor changed: Halda Therapeutics OpCo, Inc. to Janssen Research & Development, LLC
  5. Enrollment target: 33 to 190 Primary completion date: Mar 2027 to Apr 2028 · Primary endpoints: 2 to 3 · Study sites: 11 to 12 · 8 morev7 Show 11 more changesShow less
    • Primary completion date: Mar 2027 to Apr 2028
    • Primary endpoints: 2 to 3
    • Study sites: 11 to 12
    • Completion date: Mar 2027 to Apr 2030
    • Start date: Feb 24, 2025 to Feb 20, 2025
    • Interventions: HLD-0915 (Drug) to HLD-0915 Hard Capsule (Drug), HLD-0915 Soft Capsule (Drug), HLD-0915 Tablet (Drug)
    • Secondary endpoints: 11 to 6
    • Study arms: 1 to 7
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 2 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 6 to 11v6
  2. Study sites: 5 to 6v5
  3. Study sites: 2 to 5v4
  4. Start date changed from estimate of Feb 2025 to Feb 24, 2025v3
  5. Trial status: Not Yet Recruiting to Recruiting Site details revised at 2 of 2 sitesv2 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  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.
Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.
Trial Details
NCT Number NCT06800313
Lead Sponsor Janssen Research & Development, LLC
Conditions Metastatic Prostate Cancer
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov