Clinical trial · Interventional
A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)
NCT07023627CI-TRIAL-00120911MAESTRA 1recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCB123667 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
- interventionNames
- Drug: INCB123667
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
- interventionNames
- Drug: INCB123667
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Have platinum-resistant disease: * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen. * Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum. * Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as long as the sample is no older than 5 years. * Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option. * Must have received bevacizumab unless there was a contraindication for its use. * If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds. Exclusion Criteria: * Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer. * Have primary platinum-refractory disease: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy. * The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication. * Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug. * Known active CNS metastases and/or carcinomatous meningitis. * Known additional malignancy that is progressing or requires active treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.