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Stemline Therapeutics

stemline.com ↗ · Mid-Atlantic

Clinical Phase 3

Keywords: oncology cancer Blastic Plasmacytoid Dendritic Cell Neoplasm Breast Cancer Metastatic Breast Cancer Acute Myeloid Leukemia Breast Neoplasms Brain Neoplasms Neoplasms by Site Breast Diseases Central Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Advanced Breast Cancer Platinum-resistant Ovarian Cancer Adult Brain Glioblastoma Glioblastoma Multiforme Myelofibrosis Chronic Myelomonocytic Leukemia Hepatic Impairment Multiple Myeloma Hormone Receptor Positive Malignant Neoplasm of Breast HER2-Negative Breast Cancer Advanced ER+ Elacestrant Tagraxofusp MEN2312 MEN2501 SL-801 SL-901 Tagraxofusp-erzs SL-401 RAD140 RAD1901

Profile checked Oct 10, 2026

22Trials (company is sponsor)1NIH grants

Raises and deals from press releases

From the company’s own releases; this list is partial. All raises and deals

Timeline

  1. Trial start 2: A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer source ↗
  2. Trial start Phase 1: A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer source ↗
  3. Trial start —: A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy source ↗
  4. Trial start Phase 2: A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy source ↗
  5. Trial start Phase 1: A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer source ↗
  6. Trial start Phase 3: A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence source ↗
  7. Trial start —: A Registry-study of ELZONRIS in Participants With BPDCN source ↗
  8. Trial start Phase 2: ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study source ↗
  9. Trial start Phase 1: A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function source ↗
  10. Trial start Phase 1/Phase 2: Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer source ↗
  11. Trial start Phase 1/Phase 2: Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer source ↗
  12. Trial start Phase 1: Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors source ↗
  13. Trial start 3: Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer source ↗
  14. Trial start 1: Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer source ↗
  15. Trial start IB: Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer source ↗
  16. Trial start Phase 1: A Trial of a Novel XPO1 Inhibitor in Participants With Advanced Solid Tumors source ↗
  17. Trial start Phase 1/Phase 2: Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF) source ↗
  18. Trial start Phase 1/Phase 2: SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma source ↗
  19. Trial start Phase 1/Phase 2: SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission source ↗
  20. Trial start I: A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer source ↗
  21. Trial start Phase 1/Phase 2: Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia source ↗
  22. Trial start Phase 1/Phase 2: Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 22

RecordTitlePhaseStatusStartPrimary completion
NCT05386108Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast CancerPhase 1/Phase 2RecruitingAug 31, 20222026-12 (estimated)
NCT07785180A Non-interventional Study of Participants With BPDCN Treated With ChemotherapyNot listedRecruitingOct 17, 20252027-05 (estimated)
NCT06492616A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of RecurrencePhase 3RecruitingSep 27, 20242029-08 (estimated)
NCT07766018A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer2RecruitingAug 18, 20262028-10 (estimated)
NCT07785154A Registry-study of ELZONRIS in Participants With BPDCNNot listedRecruitingJun 26, 20242028-09 (estimated)
NCT06638307A First-in-Human Study of MEN2312 in Adults With Advanced Breast CancerPhase 1RecruitingOct 25, 2024Oct 24, 2027 (estimated)
NCT06456463A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive ChemotherapyPhase 2Active, not recruitingJan 14, 2025Feb 9, 2028 (estimated)
NCT07226427A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian CancerPhase 1RecruitingJan 10, 2026Dec 2, 2027 (estimated)
NCT05563220Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast CancerPhase 1/Phase 2Active, not recruitingJan 24, 2023Dec 27, 2026 (estimated)
NCT05596409ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer StudyPhase 2Active, not recruitingMay 19, 20232026-11 (estimated)
NCT03778931Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer3CompletedMay 10, 2019Aug 24, 2021 (actual)
NCT02667873A Trial of a Novel XPO1 Inhibitor in Participants With Advanced Solid TumorsPhase 1CompletedFeb 23, 2016Oct 6, 2021 (actual)
NCT02078648Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma MultiformePhase 1/Phase 2Completed2014-05Sep 1, 2017 (actual)
NCT05382936Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid TumorsPhase 1TerminatedMar 19, 2021May 5, 2023 (actual)
NCT02268253Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF)Phase 1/Phase 2CompletedFeb 10, 2016Mar 27, 2023 (actual)
NCT06126575A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic FunctionPhase 1CompletedMar 13, 2023Nov 11, 2024 (actual)
NCT02270463SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete RemissionPhase 1/Phase 2Terminated2015-022019-12 (actual)
NCT02113982Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid LeukemiaPhase 1/Phase 2Completed2014-09Feb 1, 2020 (actual)
NCT02661022SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple MyelomaPhase 1/Phase 2Terminated2016-012019-12 (actual)
NCT03088527Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer1CompletedOct 23, 2017Aug 28, 2020 (actual)
NCT02338349A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast CancerICompleted2015-012019-09 (actual)
NCT02650817Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast CancerIBCompletedApr 1, 2016Aug 30, 2018 (actual)

NIH awards 1

Annual award amounts. Total $175K.

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