NCT07023627Recruiting
A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Summary
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Countries
- Switzerland, United States, Australia, Belgium, Japan, Puerto Rico, Spain, United Kingdom
- Sponsor
- Incyte Corporation(Industry)
- Protocol no.
- INCB123667-203
- Conditions
- Ovarian Cancer
- Interventions
- Drug
Treatments studied
- INCB123667
Collaborators
ENGOT Foundation, GOG Foundation
Locations · 74
- Bellinzona, SwitzerlandIstituto Oncologico Della Svizzera Italiana (Iosi) Di BellinzonaRecruiting at this site
- Chur, SwitzerlandKantonsspital GraubundenRecruiting at this site
- Geneva, SwitzerlandGeneva University Hospitals-HugRecruiting at this site
- Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment HospitRecruiting at this site
- Mobile, United StatesUsa Health Mitchell Cancer InstituteRecruiting at this site
- Los Angeles, United StatesUniversity of California, Los Angeles Medical CenterRecruiting at this site
- San Diego, United StatesScripps Healthscripps Mercy Hospital Prebys Cancer CenterRecruiting at this site
- Washington D.C., United StatesMedstar Georgetown University HospitalRecruiting at this site
- Fort Myers, United StatesFlorida Cancer Specialists & Research InstituteRecruiting at this site
- Miami, United StatesSylvester Comprehensive Cancer CenterRecruiting at this site
- Miami Beach, United StatesMount Sinai Comprehensive Cancer CenterRecruiting at this site
- West Palm Beach, United StatesFlorida Cancer Specialists & Research InstituteRecruiting at this site
- Gainesville, United StatesNortheast Georgia Medical Center GainesvilleRecruiting at this site
- Fort Wayne, United StatesParkview Research CenterRecruiting at this site
- Iowa City, United StatesUniversity of Iowa Hospital and ClinicsRecruiting at this site
- Louisville, United StatesNorton Cancer InstituteRecruiting at this site
- Shreveport, United StatesTrials365, LlcRecruiting at this site
- Baltimore, United StatesGreater Baltimore Medical CenterRecruiting at this site
- Boston, United StatesMassachusetts General HospitalRecruiting at this site
- Worcester, United StatesUmass Memorial Medical Center, Inc.Recruiting at this site
- Ann Arbor, United StatesUniversity of Michigan Health SystemRecruiting at this site
- Minneapolis, United StatesMinnesota Oncology-MinneapolisRecruiting at this site
- Jackson, United StatesUniversity of Mississippi Medical CenterRecruiting at this site
- St Louis, United StatesWashington UniversityRecruiting at this site
- Billings, United StatesSt. Vincent Regional Hospital - West End ClinicRecruiting at this site
- Omaha, United StatesNebraska Methodist HospitalRecruiting at this site
- Hackensack, United StatesJohn Theurer Cancer Center, Hackensack University Medical CenterRecruiting at this site
- New York, United StatesLaura and Isaac Perlmutter Cancer CenterRecruiting at this site
- Syracuse, United StatesState University of New York Upstate Medical UniveRecruiting at this site
- Cincinnati, United StatesOncology Hematology Care, IncRecruiting at this site
In total, worldwide, all 74 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 15, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 44 more locations
Other identifiers
- GOG-3129 · other identifier
- 2025-521513-14-00 · other registry
- OV94 · other identifier
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.