A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Recruiting now · Phase 2

Conditions studied: Ovarian Cancer

In brief

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.

Key facts

Study ID

NCT07023627

Run by

Incyte Corporation

People needed

160

Starts

2025-11-12

Expected to finish

2027-10-24

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Oncology Hematology Care, Inc — Cincinnati, Ohio, United States (enrolling)
• Scripps Healthscripps Mercy Hospital Prebys Cancer Center — San Diego, California, United States (enrolling)
• Usa Health Mitchell Cancer Institute — Mobile, Alabama, United States (enrolling)
• Florida Cancer Specialists & Research Institute — Fort Myers, Florida, United States (enrolling)
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States (enrolling)
• University of California, Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Northeast Georgia Medical Center Gainesville — Gainesville, Georgia, United States (enrolling)
• Parkview Research Center — Fort Wayne, Indiana, United States (enrolling)
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States (enrolling)
• Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
• Trials365, Llc — Shreveport, Louisiana, United States (enrolling)
• Greater Baltimore Medical Center — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Florida Cancer Specialists & Research Institute — West Palm Beach, Florida, United States (enrolling)
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Minnesota Oncology-Minneapolis — Minneapolis, Minnesota, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• St. Vincent Regional Hospital - West End Clinic — Billings, Montana, United States (enrolling)
• Nebraska Methodist Hospital — Omaha, Nebraska, United States (enrolling)
• John Theurer Cancer Center, Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Laura and Isaac Perlmutter Cancer Center — New York, New York, United States (enrolling)
• State University of New York Upstate Medical Unive — Syracuse, New York, United States (enrolling)
• The Mark H Zangmeister Cancer Center Ohio — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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