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

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Stemline Therapeutics, Inc.
Study ID
NCT07226427
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MEN2501 — DRUG
    Oral tablet

Study Details

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.

Key Dates

Start date
Jan 10, 2026
Status verified
May 2026
Primary completion
Dec 2, 2027
Completion
Jun 2, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: MEN2501 Dose Escalation
  • Experimental: Part B: MEN2501 Dose Expansion & Optimization

Primary Outcome Measure

Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 days/cycle) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupSpringdaleArkansas72762-
Yale UniversityNew HavenConnecticut06519-
Florida Cancer Specialists & Research InstituteSarasotaFlorida34232-
Karmanos Cancer InstituteDetroitMichigan48201-
Mayo ClinicRochesterMinnesota55905-
NEXT VirginiaFairfaxVirginia22031-

Find similar trials in Springdale, AR

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Highlands Oncology Group· Springdale, ARYale University· New Haven, CTFlorida Cancer Specialists & Research Institute· Sarasota, FLKarmanos Cancer Institute· Detroit, MIMayo Clinic· Rochester, MNNEXT Virginia· Fairfax, VA

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