Recruiting

Phase 2

INCB123667A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Sponsor:

Incyte Corporation

Code:

NCT07023627

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

INCB123667

Study Details

Brief summary:

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

Conditions

Ovarian Cancer

Study ID

NCT07023627

Start date

Nov 12, 2025

Status verified date

Aug, 2026

Completion date

Oct 24, 2027

Anticipated

Primary completion date

Apr 27, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

experimental: Cohort 2

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

experimental: Cohort 3

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Interventions

INCB123667

Administered orally twice daily (BID).

Primary outcome measure

Objective Response by IRC [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423 eumedinfo@incyte.com

Locations

Usa Health Mitchell Cancer Institute

Recruiting

Mobile, Alabama, United States, 36604

University of California, Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90024-6995

Scripps Healthscripps Mercy Hospital Prebys Cancer Center

Recruiting

San Diego, California, United States, 92103

Medstar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Florida Cancer Specialists & Research Institute

Recruiting

Fort Myers, Florida, United States, 33901

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Mount Sinai Comprehensive Cancer Center

Recruiting

Miami Beach, Florida, United States, 33140

Florida Cancer Specialists & Research Institute

Recruiting

West Palm Beach, Florida, United States, 33401

Northeast Georgia Medical Center Gainesville

Recruiting

Gainesville, Georgia, United States, 30501

Parkview Research Center

Recruiting

Fort Wayne, Indiana, United States, 46845

University of Iowa Hospital and Clinics

Recruiting

Iowa City, Iowa, United States, 52242-1009

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

Trials365, Llc

Recruiting

Shreveport, Louisiana, United States, 71103

Greater Baltimore Medical Center

Recruiting

Baltimore, Maryland, United States, 21204

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Minnesota Oncology-Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55404

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Washington University

Recruiting

St Louis, Missouri, United States, 63110

St. Vincent Regional Hospital - West End Clinic

Recruiting

Billings, Montana, United States, 59106

Nebraska Methodist Hospital

Recruiting

Omaha, Nebraska, United States, 68114

John Theurer Cancer Center, Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Laura and Isaac Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

State University of New York Upstate Medical Unive

Recruiting

Syracuse, New York, United States, 13210

Oncology Hematology Care, Inc

Recruiting

Cincinnati, Ohio, United States, 45242

The Mark H Zangmeister Cancer Center Ohio

Recruiting

Columbus, Ohio, United States, 43219

The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

Recruiting

Hilliard, Ohio, United States, 43026

Penn State College of Medicine

Recruiting

Hershey, Pennsylvania, United States, 17033

Texas Oncology-Austin Center

Recruiting

Austin, Texas, United States, 78731

Texas Oncology-San Antonio Medical Center Pharmacy

Recruiting

San Antonio, Texas, United States, 78229

Texas Oncology-Tyler

Recruiting

Tyler, Texas, United States, 75702

Utah Cancer Specialists

Recruiting

Salt Lake City, Utah, United States, 84106

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24016-4962

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Froedtert & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Incyte Corporation

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

INCB123667

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-08-06.