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Clinical Trials in Spain / NCT07226427
Recruiting Phase 1

A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer

NCT07226427 · tracked via the Priya Life Science Spain tracker
Sponsor
Stemline Therapeutics, Inc
Phase
Phase 1
Started
2026-01-10
Last updated
2026-07-06

Condition(s) studied

Platinum-resistant Ovarian Cancer

Investigational drug(s) / intervention(s)

MEN2501

MEN2501: Oral tablet

Study summary

This is a first-in-human, open-label, dose-escalation, dose-optimization trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of MEN2501 monotherapy in adult participants with platinum-resistant ovarian cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Key Exclusion Criteria: * Participants with primary platinum-refractory disease. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

  • Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs) — Cycle 1 (28 days/cycle)
  • Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501 — Up to approximately 6 months

Trial sites (15)

FacilityCityRegionStatus
Highlands Oncology Group Springdale Arkansas Recruiting
Yale University New Haven Connecticut Recruiting
Florida Cancer Specialists & Research Institute Sarasota Florida Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
NEXT Virginia Fairfax Virginia Recruiting
Icon Cancer Centre South Brisbane Queensland Recruiting
Cancer Research SA Aberfoyle Park Australia Recruiting
Hospital Universitario Dexeus - Grupo Quironsalud Barcelona Spain Recruiting
Clínica Universidad Navarra Madrid Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Universitario HM Sanchinarro Madrid Spain Recruiting
Clínica Universidad de Navarra Pamplona Spain Recruiting
Hospital Quironsalud Madrid Pozuelo de Alarcón Spain Recruiting

More Stemline Therapeutics, Inc. trials in Spain

Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer Recruiting
A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy Recruiting
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence Recruiting
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer Active, not recruiting
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer Recruiting

Other trials for the same condition

A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies Active, not recruiting
Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07226427 on ClinicalTrials.gov ↗ ← All trials in Spain