Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
286
Countries
1
Sites
8
Advanced ER+/HER2- Breast Cancer
Key facts
- Sponsor
- Stemline Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Feb 2026 → ongoing
- Decision date (initial)
- 2025-12-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514661-19-01
- WHO UTN
- U1111-1308-5349
- ClinicalTrials.gov
- NCT06638307
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced ER+/HER2- Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stemline Therapeutics Inc.
- Sponsor organisation
- Stemline Therapeutics Inc.
- Address
- 750 Lexington Avenue
- City
- New York
- Postcode
- 10022-1200
- Country
- United States
Scientific contact point
- Organisation
- Stemline Therapeutics Inc.
- Contact name
- Clinical Development and Clinical Operations
Public contact point
- Organisation
- Stemline Therapeutics Inc.
- Contact name
- Clinical Development and Clinical Operations
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 46 | 8 |
| Rest of world
United States, United Kingdom
|
— | 240 | — |
Investigational sites
Hospital Universitario 12 De Octubre
03408: Oncología Médica, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Y Politecnico La Fe
03407:Oncología Médica, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinico San Carlos
03406:Oncología Médica, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Beata Maria Ana
#03403 :Oncología medica, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario Hm Sanchinarro
#03401: START, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
03405:Oncologia Médica y Hematologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
03404:Oncología medica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
#03402 :Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2026-02-18 | 2026-03-04 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-12 | Spain | Acceptable 2025-12-26
|
2025-12-29 |