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TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Study acronym: TulmiSTAR-02
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 6 changed
See other at-risk trials from Novartis

Record History

  1. Primary endpoint(s) modified Interventions modified · Eligibility criteria expanded, about 173 words · Secondary endpoints: 25 to 21 · 2 more Show 5 more changesShow less
    • Interventions modified
    • Eligibility criteria expanded, about 173 words
    • Secondary endpoints: 25 to 21
    • Study description expanded, about 208 words
    • Site details revised at 3 of 31 sites
  2. Study description shortened, about 14 words Site details revised at 4 of 31 sitesv20 Show 1 more changeShow less
    • Site details revised at 4 of 31 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 30 to 31v19
  4. Trial sites expanded: 25 → 29 locationsv18
  5. Study sites: 25 to 29v17
  6. Primary endpoint(s) modified Enrollment increased: 155 → 181 participants · Study sites: 24 to 25v16 Show 2 more changesShow less
    • Enrollment increased: 155 → 181 participants
    • Study sites: 24 to 25

    See this version in full on ClinicalTrials.gov ↗

  7. Primary endpoints revised (6) Enrollment target: 155 to 181 · Study sites: 22 to 24 · Eligibility criteria expanded, about 18 words · 1 morev15 Show 4 more changesShow less
    • Enrollment target: 155 to 181
    • Study sites: 22 to 24
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (25)

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 21 to 22v14
  9. Primary and study completion pushed from Jun 4, 2032 to Aug 2, 2032 Trial sites expanded: 14 → 20 locationsv13 Show 1 more changeShow less
    • Trial sites expanded: 14 → 20 locations
  10. Study sites: 14 to 20v12
  11. Study sites: 13 to 14v11
  12. Study sites: 12 to 13v10
  13. Study sites: 10 to 12v9
  14. Re-verified, no change to tracked fieldsv8
  15. Enrollment target: 181 to 155 Study sites: 7 to 10v7 Show 1 more changeShow less
    • Study sites: 7 to 10
  16. Study sites: 6 to 7v6
  17. Enrollment target: 155 to 181 Eligibility criteria expanded, about 98 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 98 words

    See this version in full on ClinicalTrials.gov ↗

  18. Study sites: 2 to 6 Start date changed from estimate of Nov 24, 2025 to Jan 13, 2026v4 Show 1 more changeShow less
    • Start date changed from estimate of Nov 24, 2025 to Jan 13, 2026
  19. Enrollment target: 203 to 155 Study sites: 1 to 2v3 Show 1 more changeShow less
    • Study sites: 1 to 2
  20. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary and study completion dates: May 14, 2032 to Jun 4, 2032 · Start date: Nov 3, 2025 to Nov 24, 2025v2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: May 14, 2032 to Jun 4, 2032
    • Start date: Nov 3, 2025 to Nov 24, 2025
  21. 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.
Novartis
555 trials monitored
See 31 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer (mHSPC). Phase I aims to determine the recommended dose(s) for expansion (RDE) of tulmimetostat in combination with darolutamide or abiraterone. Phase II is designed to further evaluate the efficacy and safety of tulmimetostat in combination with darolutamide compared with darolutamide alone in participants with mHSPC.
Trial Details
NCT Number NCT07190300
Lead Sponsor Novartis Pharmaceuticals
Conditions Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Enrollment 181 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov