Clinical trial • Phase I • Oncology
MEN2312 (KAT6 inhibitor) for Advanced ER-positive HER2-negative breast cancer | Hormone receptor positive HER2 negative breast cancer
Phase I trial of MEN2312 (KAT6 inhibitor) for Advanced ER-positive HER2-negative breast cancer | Hormone receptor positive HER2 negative breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced ER-positive HER2-negative breast cancer | Hormone receptor positive HER2 negative breast cancer
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-09-2025
- First CTIS Authorization Date
- 29-12-2025
Trial design
Phase I trial across 8 sites in Spain.
- Target Sample Size
- 240
Recruitment
- Planned Sample Size
- 240
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 240
Spain
- Earliest CTIS Part Ii Submission Date
- 02-12-2025
- Latest Decision Or Authorization Date
- 29-12-2025
- Processing Time Days
- 27
- Number Of Sites
- 8
- Number Of Participants
- 46
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- #03402 :Oncología
- Contact Person Name
- Bernard Doger De Speville Uribe
- Contact Person Email
- bernard.doger@startmadrid.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- #03401: START
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- 03405:Oncologia Médica y Hematologia
- Contact Person Name
- Juan Cejalvo Andújar
- Contact Person Email
- juanmitch5@hotmail.com
- Site Name
- Hospital Beata Maria Ana
- Department Name
- #03403 :Oncología medica
- Contact Person Name
- Javier Cortés Castán
- Contact Person Email
- javier.cortes@maj3.health.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- 03406:Oncología Médica
- Contact Person Name
- José García Sáenz
- Contact Person Email
- jgsaenz@salud.madrid.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- 03408: Oncología Médica
- Contact Person Name
- Manuel Alva Bianchi
- Contact Person Email
- malvabianchi@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- 03407:Oncología Médica
- Contact Person Name
- Ana Santaballa Bertrán
- Contact Person Email
- santaballa_ana@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- 03404:Oncología medica
- Contact Person Name
- Cristina Saura Manich
- Contact Person Email
- csaura@vhio.net
Sponsor
Primary sponsor
- Full Name
- Stemline Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- MEN2312
- Active Substance
- MEN2312 (KAT6 inhibitor)
- Modality
- Small molecule
- First In Human
- Yes
- Combination Treatment
- Yes
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