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NCT07023627PHASE2Recruiting

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

Incyte Corporation

Start Date

11/12/2025

Completion Date

10/24/2027

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

Age Range: 18 years to 99 years

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.

Interventions

DRUG

INCB123667

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Conditions

Ovarian Cancer

Locations

Usa Health Mitchell Cancer Institute

Mobile, Alabama 36604

United States

University of California, Los Angeles Medical Center

Los Angeles, California 90024-6995

United States

Scripps Healthscripps Mercy Hospital Prebys Cancer Center

San Diego, California 92103

United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia 20010

United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida 33901

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida 33140

United States

Florida Cancer Specialists & Research Institute

West Palm Beach, Florida 33401

United States

Northeast Georgia Medical Center Gainesville

Gainesville, Georgia 30501

United States

Parkview Research Center

Fort Wayne, Indiana 46845

United States

University of Iowa Hospital and Clinics

Iowa City, Iowa 52242-1009

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

Trials365, Llc

Shreveport, Louisiana 71103

United States

Greater Baltimore Medical Center

Baltimore, Maryland 21204

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Umass Memorial Medical Center, Inc.

Worcester, Massachusetts 01605

United States

University of Michigan Health System

Ann Arbor, Michigan 48109

United States

Minnesota Oncology-Minneapolis

Minneapolis, Minnesota 55404

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216

United States

Washington University

St Louis, Missouri 63110

United States

St. Vincent Regional Hospital - West End Clinic

Billings, Montana 59106

United States

Nebraska Methodist Hospital

Omaha, Nebraska 68114

United States

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Laura and Isaac Perlmutter Cancer Center

New York, New York 10016

United States

State University of New York Upstate Medical Unive

Syracuse, New York 13210

United States

Oncology Hematology Care, Inc

Cincinnati, Ohio 45242

United States

The Mark H Zangmeister Cancer Center Ohio

Columbus, Ohio 43219

United States

The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

Hilliard, Ohio 43026

United States

Penn State College of Medicine

Hershey, Pennsylvania 17033

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Texas Oncology-Austin Center

Austin, Texas 78731

United States

Texas Oncology-San Antonio Medical Center Pharmacy

San Antonio, Texas 78229

United States

Texas Oncology-Tyler

Tyler, Texas 75702

United States

Utah Cancer Specialists

Salt Lake City, Utah 84106

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Carilion Clinic

Roanoke, Virginia 24016-4962

United States

West Virginia University

Morgantown, West Virginia 26506

United States

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Blacktown Cancer & Haematology Centre-Blacktown Hospital

Blacktown, New South Wales 02148

Australia

Concord General Repatriation Hospital

Concord, New South Wales 02139

Australia

Burnside War Memorial Hospital - the Brian Fricker Oncology Centre

Adelaide, South Australia 05065

Australia

Hobart Hospital-Royal Hobart Hospital

Hobart, Tasmania 07000

Australia

Cancer Research Sa (Crsa)

Adelaide, 05000

Australia

Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet

Brussels, 01070

Belgium

Cliniques Universitaires St Luc Ucl

Brussels, B-1200

Belgium

Az Groeninge

Kortrijk, 08500

Belgium

Universitair Ziekenhuis Leuven

Leuven, 03000

Belgium

Chu Liege

Liège, 04000

Belgium

Hyogo Cancer Center

Akashi-shi, 673-8558

Japan

Saitama Medical University International Medical Center

Hidaka-shi, 350-1298

Japan

The Cancer Institute Hospital of Jfcr

Kōtoku, 135-8550

Japan

Kurume University Hospital

Kurume, 830-0011

Japan

Shikoku Cancer Center

Matsuyama, 791-0280

Japan

Hokkaido University Hospital

Sapporo, 060-8648

Japan

Shizuoka Cancer Center

Sunto-gun, 411-8777

Japan

Panoncology Trials

San Juan, PR 00935

Puerto Rico

Hospital Universitario Vall D'Hebron

Barcelona, 08035

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Instituto Catalan de Oncologia - Hospital Duran I Reynals

Barcelona, 08908

Spain

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Institut Catala D'Oncologia Girona

Girona, 17007

Spain

Clinica Universidad de Navarra - Sede Madrid

Madrid, 28027

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Virgen de La Arrixaca

Murcia, 30120

Spain

Fundacion Instituto Valenciano de Oncologia

Valencia, 46009

Spain

Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)

Valencia, 46010

Spain

Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona

Bellinzona, 06500

Switzerland

Kantonsspital Graubunden

Chur, 07000

Switzerland

Geneva University Hospitals-Hug

Geneva, 01211

Switzerland

Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit

Lausanne, 01011

Switzerland

Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

London, SE1 9RT

United Kingdom

Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust

London, SM2 5PT

United Kingdom

Hammersmith Hospital - Imperial College Healthcare Nhs Trust

London, W12 0HS

United Kingdom

The Christie Nhs Foundation Trust

Manchester Greater, M204BX

United Kingdom