Health TrialsbyHealthPanel

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

ConditionPlatinum-resistant Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStemline Therapeutics, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Disqualifiers

Participants with primary platinum-refractory disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MEN2501

    Drug

    Oral tablet

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Part A: MEN2501 Dose EscalationExperimental treatment 1 intervention
Group B: Part B: MEN2501 Dose Expansion & OptimizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs)

Time frame
Cycle 1 (28 days/cycle)
2

Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501

Time frame
Up to approximately 6 months

Secondary outcomes

1

Number of Participants with Treatment-emergent Adverse Events

Time frame
Up to approximately 7 months
2

Overall Response Rate

Time frame
Up to approximately 7 months
3

Duration of Objective Response

Time frame
Up to approximately 7 months
4

Clinical Benefit Rate

Time frame
Up to approximately 7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stemline Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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