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Clinical Trials in the USA / NCT07023627
Recruiting Phase 2

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

NCT07023627 · tracked via the Priya Life Science USA tracker
Sponsor
Incyte Corporation
Phase
Phase 2
Started
2025-11-12
Last updated
2026-09-15

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

INCB123667

INCB123667: Administered orally twice daily (BID).

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
Usa Health Mitchell Cancer Institute Mobile Alabama Recruiting
University of California, Los Angeles Medical Center Los Angeles California Recruiting
Scripps Healthscripps Mercy Hospital Prebys Cancer Center San Diego California Recruiting
Medstar Georgetown University Hospital Washington D.C. District of Columbia Recruiting
Florida Cancer Specialists & Research Institute Fort Myers Florida Recruiting
Sylvester Comprehensive Cancer Center Miami Florida Recruiting
Mount Sinai Comprehensive Cancer Center Miami Beach Florida Recruiting
Florida Cancer Specialists & Research Institute West Palm Beach Florida Recruiting
Northeast Georgia Medical Center Gainesville Gainesville Georgia Recruiting
Parkview Research Center Fort Wayne Indiana Recruiting
University of Iowa Hospital and Clinics Iowa City Iowa Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
Trials365, Llc Shreveport Louisiana Recruiting
Greater Baltimore Medical Center Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Umass Memorial Medical Center, Inc. Worcester Massachusetts Recruiting
University of Michigan Health System Ann Arbor Michigan Recruiting
Minnesota Oncology-Minneapolis Minneapolis Minnesota Recruiting
University of Mississippi Medical Center Jackson Mississippi Recruiting
Washington University St Louis Missouri Recruiting
St. Vincent Regional Hospital - West End Clinic Billings Montana Recruiting
Nebraska Methodist Hospital Omaha Nebraska Recruiting
John Theurer Cancer Center, Hackensack University Medical Center Hackensack New Jersey Recruiting
Laura and Isaac Perlmutter Cancer Center New York New York Recruiting
State University of New York Upstate Medical Unive Syracuse New York Recruiting
Oncology Hematology Care, Inc Cincinnati Ohio Recruiting
The Mark H Zangmeister Cancer Center Ohio Columbus Ohio Recruiting
The Ohio State University Wexner Medical Center Division of Gynecologic Oncology Hilliard Ohio Recruiting
Penn State College of Medicine Hershey Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Texas Oncology-Austin Center Austin Texas Recruiting
Texas Oncology-San Antonio Medical Center Pharmacy San Antonio Texas Recruiting
Texas Oncology-Tyler Tyler Texas Recruiting
Utah Cancer Specialists Salt Lake City Utah Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Carilion Clinic Roanoke Virginia Recruiting
West Virginia University Morgantown West Virginia Recruiting
Froedtert & the Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Blacktown Cancer & Haematology Centre-Blacktown Hospital Blacktown New South Wales Recruiting
Concord General Repatriation Hospital Concord New South Wales Recruiting

+ 34 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07023627 on ClinicalTrials.gov ↗ ← All trials in the USA