NCT07023627 A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
| NCT ID | NCT07023627 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Incyte Corporation |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2027-04-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2025-11-12 with a primary completion date of 2027-04-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
Eligibility Criteria
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.
Contact & Investigator
Incyte Medical Monitor
STUDY DIRECTOR
Incyte Corporation
Frequently Asked Questions
Who can join the NCT07023627 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07023627 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07023627 currently recruiting?
Yes, NCT07023627 is actively recruiting participants. Contact the research team at medinfo@incyte.com for enrollment information.
Where is the NCT07023627 trial being conducted?
This trial is being conducted at Mobile, United States, Los Angeles, United States, San Diego, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT07023627 clinical trial?
NCT07023627 is sponsored by Incyte Corporation. The principal investigator is Incyte Medical Monitor at Incyte Corporation. The trial plans to enroll 160 participants.
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