Clinical trial · Interventional
A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer
A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer
NCT07226427CI-TRIAL-00116778recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum-resistant Ovarian Cancer | Platinum-Resistant Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEN2501 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: MEN2501 Dose Escalation
- interventionNames
- Drug: MEN2501
- type
- EXPERIMENTAL
- label
- Part B: MEN2501 Dose Expansion & Optimization
- interventionNames
- Drug: MEN2501
Primary outcomes (2)
- measure
- Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs)
- timeFrame
- Cycle 1 (28 days/cycle)
- measure
- Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.