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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Oral tablet
NEXT Virginia
Fairfax, Virginia, United States
RECRUITINGPart 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
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
Stemline Trials
CONTACT
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