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A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Jun 2026 → Oct 24, 2027
See other at-risk trials from Stemline Therapeutics, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 44 to 45v23
  2. Primary completion pushed from Jun 2026 to Oct 24, 2027
    • Study completion pushed from Oct 2026 to Oct 23, 2029
    • Study sites: 42 to 44
    v22
  3. Trial sites expanded: 36 → 42 locations
    • Eligibility criteria shortened, about 6 words
    v21
  4. Trial sites expanded: 32 → 36 locationsv20
  5. Study sites: 30 to 32v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 20 to 30v18
  2. Study sites: 19 to 20v17
  3. Primary completion date: Oct 2025 to Jun 2026
    • Study sites: 38 to 19
    v16
  4. Enrollment target: 124 to 240
    • Eligibility criteria expanded, about 82 words
    • Secondary endpoints revised (10)
    v15
  5. Study sites: 26 to 38v14
  6. Site details revised at 2 of 26 sitesv13
  7. Study sites: 19 to 26v12
  8. Site details revised at 1 of 19 sitesv11
  9. Site details revised at 1 of 19 sitesv10
  10. Study sites: 36 to 19v9
  11. Study sites: 37 to 36v8
  12. Re-verified, no change to tracked fieldsv7
  13. Study sites: 29 to 37v6
  14. Site details revised at 4 of 29 sitesv5
  15. Study sites: 26 to 29
    • Start date changed from estimate of Oct 2024 to Oct 25, 2024
    v4
  16. Site details revised at 4 of 26 sitesv3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 22 to 26
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
Trial Details
NCT Number NCT06638307
Lead Sponsor Stemline Therapeutics, Inc.
Conditions
(from sponsor)		 Advanced Breast Cancer
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov