Platinum-resistant Ovarian CancerPhase 1NCT07226427
A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer
A Phase 1 study testing MEN2501 in people with Platinum-resistant Ovarian Cancer, run by Stemline Therapeutics, Inc. at 15 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum-resistant Ovarian Cancer
- What is being tested?
- MEN2501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 10 Jan 2026to 2 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Who cannot join
- Participants with primary platinum-refractory disease.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Stemline Trials contact
cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com
15 sites in 3 countries
United States7 sites, 7 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
Yale University
New Haven, Connecticut, 06519
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Florida Cancer Specialists & Research Institute
Sarasota, Florida, 34232
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario Dexeus - Grupo Quironsalud
Barcelona, 08028
- Recruiting
Clínica Universidad Navarra
Madrid, 28027
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
- Recruiting
Clínica Universidad de Navarra
Pamplona, 31008
- Recruiting
Hospital Quironsalud Madrid
Pozuelo de Alarcón, 28226
Australia2 sites, 2 recruiting
- Recruiting
Cancer Research SA
Aberfoyle Park, 5000
- Recruiting
Icon Cancer Centre
South Brisbane, Queensland, 4101
About this study
Official title: A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer
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.
- Conditions
- Platinum-resistant Ovarian Cancer
- Being tested
- MEN2501
- Keywords
- MEN2501, First-in-Human, Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEN2501Drug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Part A: MEN2501 Dose Escalation | Experimental | Not described Receives: Drug: MEN2501 |
| Part B: MEN2501 Dose Expansion & Optimization | Experimental | Not described Receives: Drug: MEN2501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs)
Measured: Cycle 1 (28 days/cycle)
Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501
Measured: Up to approximately 6 months
Secondary outcomes (8)
Number of Participants with Treatment-emergent Adverse Events
Measured: Up to approximately 7 months
Overall Response Rate
Measured: Up to approximately 7 months
Duration of Objective Response
Measured: Up to approximately 7 months
Clinical Benefit Rate
Measured: Up to approximately 7 months
Progression-free Survival
Measured: Up to approximately 12 months
Overall Survival
Measured: Up to approximately 12 months
Time To Response
Measured: Up to approximately 7 months
Area Under the Plasma Concentration-time Curve (AUC) of MEN2501
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start10 Jan 2026
- Primary completion2 Dec 2027 (estimated)
- Study completion2 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Stemline Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants enrolled in the Part B dose expansion will be randomized between expansion doses.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Stemline Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226427
- Sponsor's protocol ID
- MEN2501-01
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07226427
- Acronym / sponsor ID
- MEN2501-01
- Conditions
- Platinum-resistant Ovarian Cancer
- Keywords
- MEN2501, First-in-Human, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 2 Jun 2028 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants enrolled in the Part B dose expansion will be randomized between expansion doses.
| Arm | Type | Receives |
|---|---|---|
| Part A: MEN2501 Dose Escalation | Experimental | Drug: MEN2501 |
| Part B: MEN2501 Dose Expansion & Optimization | Experimental | Drug: MEN2501 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Key exclusion criteria (2 listed)
- Participants with primary platinum-refractory disease.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEN2501Oral tablet | Drug | Part A: MEN2501 Dose Escalation, Part B: MEN2501 Dose Expansion & Optimization |
Primary outcome
Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: Cycle 1 (28 days/cycle)
Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501
Time frame: Up to approximately 6 months
8 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to approximately 7 months
Overall Response Rate
Time frame: Up to approximately 7 months
Duration of Objective Response
Time frame: Up to approximately 7 months
Clinical Benefit Rate
Time frame: Up to approximately 7 months
Progression-free Survival
Time frame: Up to approximately 12 months
Overall Survival
Time frame: Up to approximately 12 months
Time To Response
Time frame: Up to approximately 7 months
Area Under the Plasma Concentration-time Curve (AUC) of MEN2501
Time frame: Up to approximately 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stemline Trials contact
cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com
Medical Director study director
Stemline Therapeutics, Inc.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEN2501 in people with Platinum-resistant Ovarian Cancer, run by Stemline Therapeutics, Inc. at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Spain, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stemline Trials (1-877-332-7961, cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs) (time frame: Cycle 1 (28 days/cycle)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.