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Stemline Therapeutics, Inc.

Stemline Therapeutics, Inc. logo
🇺🇸United States
Ownership
Public, Subsidiary
Established
2003-08-01
Employees
100
Market Cap
-
Website
http://www.stemline.com

Clinical Trials

25

Active:5
Completed:9

Trial Phases

3 Phases

Phase 1:20
Phase 2:2
Phase 3:2

Drug Approvals

2

FDA:2

Drug Approvals

ORSERDU

Approval Date
Nov 21, 2023
FDA

Elzonris

Approval Date
Jul 31, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (25 trials with phase data)• Click on a phase to view related trials

Phase 1
20 (80.0%)
Phase 2
2 (8.0%)
Phase 3
2 (8.0%)
phase_1_2
1 (4.0%)

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

Phase 1
Recruiting
Conditions
Advanced Breast Cancer
Interventions
First Posted Date
2024-10-15
Last Posted Date
2025-06-19
Lead Sponsor
Stemline Therapeutics, Inc.
Target Recruit Count
124
Registration Number
NCT06638307
Locations
🇺🇸

Highlands Oncology Group, Springdale, Arkansas, United States

🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

🇺🇸

UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

and more 16 locations

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)

Phase 3
Recruiting
Conditions
Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence
First Posted Date
2024-07-09
Last Posted Date
2025-07-09
Lead Sponsor
Stemline Therapeutics Inc.
Target Recruit Count
1972
Registration Number
2024-515445-42-00
Locations
🇺🇸

Southern Cancer Center, PC, Daphne, Alabama, United States

🇺🇸

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

and more 296 locations

A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2024-06-13
Last Posted Date
2025-07-08
Lead Sponsor
Stemline Therapeutics, Inc.
Target Recruit Count
76
Registration Number
NCT06456463
Locations
🇺🇸

Fred Hutch Cancer Center, Seattle, Washington, United States

🇺🇸

University of California, Los Angeles, Los Angeles, California, United States

🇺🇸

Stanford University Medical Center, Palo Alto, California, United States

and more 30 locations

A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function

Phase 1
Completed
Conditions
Hepatic Impairment
Interventions
First Posted Date
2023-11-13
Last Posted Date
2024-11-19
Lead Sponsor
Stemline Therapeutics, Inc.
Target Recruit Count
16
Registration Number
NCT06126575
Locations
🇺🇸

Inland Empire Clinical Trials, LLC, Yucaipa, California, United States

🇺🇸

Floridian Clinical Research, Miami, Florida, United States

🇺🇸

American Research Corp, San Antonio, Texas, United States

ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

Phase 2
Active, not recruiting
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2022-10-27
Last Posted Date
2025-06-05
Lead Sponsor
Stemline Therapeutics, Inc.
Target Recruit Count
61
Registration Number
NCT05596409
Locations
🇺🇸

Highlands Oncology Group, PA, Springdale, Arkansas, United States

🇺🇸

OPN Healthcare, Arcadia, California, United States

🇺🇸

University of Colorado Cancer Center, Aurora, Colorado, United States

and more 31 locations
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