Clinical trial • Phase I • Oncology

MEN2501 for Platinum-resistant ovarian cancer | Ovarian cancer

Phase I trial of MEN2501 for Platinum-resistant ovarian cancer | Ovarian cancer. 97 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Platinum-resistant ovarian cancer | Ovarian cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
24-11-2025
First CTIS Authorization Date
23-03-2026

Trial design

Phase I trial across 6 sites in Spain.

Target Sample Size
97

Eligibility

Recruits 97 No vulnerable populations selected; only female subjects are eligible; consent or assent handling not specified in the provided record..

Vulnerable Population
No vulnerable populations selected; only female subjects are eligible; consent or assent handling not specified in the provided record.

Recruitment

Planned Sample Size
97
Recruitment Window Months
26

Geography

Total Number Of Sites
6
Total Number Of Participants
97

Spain

Earliest CTIS Part Ii Submission Date
25-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
26
Number Of Sites
6
Number Of Participants
23

Sites

Site Name
Clinica Universidad De Navarra
Department Name
034-02: Oncología
Principal Investigator Name
Antonio Jose Gonzalez Martin
Principal Investigator Email
agonzalezma@unav.es
Contact Person Name
Antonio Jose Gonzalez Martin
Contact Person Email
agonzalezma@unav.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
034-05: Oncologia Médica y Hematologia
Principal Investigator Name
José Alejandro Pérez Fidalgo
Principal Investigator Email
afidalgo@incliva.es
Contact Person Name
José Alejandro Pérez Fidalgo
Contact Person Email
afidalgo@incliva.es
Site Name
Instituto Oncologico Dr. Rosell S.L.
Department Name
034-03: Oncology
Principal Investigator Name
Alejandro Adolfo Martínez Bueno
Principal Investigator Email
amartinez@oncorosell.com
Contact Person Name
Alejandro Adolfo Martínez Bueno
Contact Person Email
amartinez@oncorosell.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
034-01: Medical Oncology
Principal Investigator Name
Valentina Boni
Principal Investigator Email
vboni@nextoncology.eu
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
034-04: Oncology
Principal Investigator Name
Ramon Yarza Barrio
Principal Investigator Email
ramon.yarza@startmadrid.com
Contact Person Name
Ramon Yarza Barrio
Contact Person Email
ramon.yarza@startmadrid.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
034-06: Medical Oncology
Principal Investigator Name
Ainhoa Madariaga
Principal Investigator Email
ainhoama@hotmail.com
Contact Person Name
Ainhoa Madariaga
Contact Person Email
ainhoama@hotmail.com

Sponsor

Primary sponsor

Full Name
Stemline Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
MEN2501

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