A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Incyte Corporation (industry)

Phase: 2

Start date: June 17, 2025

Planned enrollment: 160

Trial ID: NCT07023627
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More trial details at ClinicalTrials.gov More info

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Goal: Evaluate the antitumor activity and safety of the selective CDK2 inhibitor INCB123667 in platinum-resistant ovarian cancer with Cyclin E1 overexpression, using independently reviewed objective response as the primary endpoint.

Patients: Adults with histologically confirmed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with platinum-resistant disease after 1–4 prior systemic regimens, prior bevacizumab required unless contraindicated, and prior mirvetuximab soravtansine required if tumor is FRα-positive unless medically contraindicated. Archival tumor tissue within 5 years or willingness for pretreatment biopsy is required. Key exclusions include non–high-grade serous histologies, primary platinum-refractory disease, untreated/active CNS metastases, significant recent cardiac disease, and other active malignancies.

Design: Phase 2, multicohort, single-arm, nonrandomized study enrolling approximately 160 participants. All cohorts receive INCB123667 with dosing guided by tumor Cyclin E1 expression; efficacy is assessed by independent review per RECIST v1.1.

Treatments: INCB123667, an oral, highly selective CDK2 inhibitor designed for tumors characterized by CCNE1 amplification/overexpression. CDK2 inhibition aims to counter Cyclin E–driven cell-cycle progression, with pharmacodynamic evidence of CDK2 substrate inhibition and growth arrest in CCNE1-high models. Early clinical data from Phase 1a/1b suggest single-agent activity in platinum-resistant ovarian cancer, with reported objective response rates around 24–33% in expansion cohorts and a generally manageable safety profile predominantly featuring low-grade hematologic and gastrointestinal events. In this study, INCB123667 is dosed per protocol stratified by cyclin E1 expression across three experimental cohorts.

Outcomes: Primary: Objective response by independent review committee (RECIST v1.1). Secondary: Duration of response, progression-free survival, objective response by investigator, duration of response by investigator, progression-free survival by investigator, overall survival, and safety including treatment-emergent adverse events and events leading to dose modifications or discontinuation. All time-to-event endpoints are followed for up to approximately 2 years.

Burden on patient: Moderate. The trial uses an oral agent, which typically reduces clinic time, but requires baseline tumor tissue submission and may necessitate a pretreatment biopsy if archival tissue is unavailable. Regular radiographic assessments for RECIST-based independent review, clinical evaluations, laboratory monitoring, and safety surveillance are anticipated at a frequency similar to other phase 2 oncology studies (for example, imaging every 6–9 weeks). No intensive pharmacokinetic sampling is indicated, but potential dose modifications and monitoring for hematologic toxicity may add visit frequency early in treatment. Travel and visit burden should be comparable to other single-agent phase 2 studies in the platinum-resistant setting.

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Concord General Repatriation Hospital

Concord, New South Wales, 02139, Australia

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Blacktown Cancer & Haematology Centre-Blacktown Hospital

Blacktown, New South Wales, 02148, Australia

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Burnside War Memorial Hospital - the Brian Fricker Oncology Centre

Adelaide, South Australia, 05065, Australia

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Hobart Hospital-Royal Hobart Hospital

Hobart, Tasmania, 07000, Australia

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Southern Oncology Clinical Research Unit

South Australia, 05042, Australia

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Cancer Research Sa (Crsa)

Adelaide, 05000, Australia

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Cliniques Universitaires St Luc Ucl

Brussels, B-1200, Belgium

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Az Groeninge Campus Kennedylaan

Kortrijk, 08500, Belgium

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Universitair Ziekenhuis Leuven

Leuven, 03000, Belgium

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Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel

Brussels, 01070, Belgium

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Chu Liege

Liège, 04000, Belgium

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Hyogo Cancer Center

Akashi-shi, 673-8558, Japan

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Saitama Medical University International Medical Center

Hidaka-shi, 350-1298, Japan

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The Cancer Institute Hospital of Jfcr

Kōtoku, 135-8550, Japan

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Kurume University Hospital

Kurume, 830-0011, Japan

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Shikoku Cancer Center

Matsuyama, 791-0280, Japan

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Hokkaido University Hospital

Sapporo, 060-8648, Japan

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Shizuoka Cancer Center

Sunto-gun, 411-8777, Japan

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Panoncology Trials

San Juan, PR, 00935, Puerto Rico

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Hospital Clinic de Barcelona (Hospital Clinic I Provincial)

Barcelona, 08036, Spain

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

Valencia, 46010, Spain

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Hospital Universitario Virgen de La Arrixaca

Murcia, 30120, Spain

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Hospital Universitario La Paz

Madrid, 28046, Spain

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Clinica Universidad de Navarra - Sede Madrid

Madrid, 28027, Spain

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Institut Catala D'Oncologia Girona

Girona, 17007, Spain

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Instituto Catalan de Oncologia - Hospital Duran I Reynals

Barcelona, 08908, Spain

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Hospital Universitario Vall D'Hebron

Barcelona, 08035, Spain

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Kantonsspital Graubunden

Chur, 07000, Switzerland

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Geneva University Hospitals-Hug

Geneva, 01211, Switzerland

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Istituto Oncologico Della Svizzera Italiana

Bellinzona, 06500, Switzerland

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

Lausanne, 01011, Switzerland

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Kantonsspital - Onkologisches Ambulatorium

Sankt Gallen, 09007, Switzerland

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Western General Hospital - Lothian Health Board

Edinburgh, EH4 2XU, United Kingdom

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St Bartholomew'S Hospital

London, EC1A 7BE, United Kingdom

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

London, SE1 9RT, United Kingdom

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

London, SM2 5PT, United Kingdom

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Hammersmith Hospital - Imperial College Healthcare Nhs Trust

London, W12 0HS, United Kingdom

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The Christie Nhs Foundation Trust

Manchester Greater, M204BX, United Kingdom

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Usa Health Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

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Uams Winthrop P Rockefeller Cancer Institute

Little Rock, Arkansas, 72205, United States

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University of California, Los Angeles Medical Center

Los Angeles, California, 90024-6995, United States

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Scripps Healthscripps Mercy Hospital Prebys Cancer Center

San Diego, California, 92103, United States

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Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

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Mayo Clinic

Jacksonville, Florida, 32224, United States

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Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

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Northeast Georgia Medical Center Gainesville

Gainesville, Georgia, 30501, United States

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Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

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Parkview Research Center

Fort Wayne, Indiana, 46845, United States

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Community Health Network, Inc.

Indianapolis, Indiana, 46250, United States

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University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242-1009, United States

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Norton Cancer Institute

Louisville, Kentucky, 40207, United States

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Trials365, Llc

Shreveport, Louisiana, 71133, United States

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Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

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John Hopkins University-School of Medicine

Baltimore, Maryland, 21287, United States

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Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

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St Joseph Mercy Hospital-Gynecologic Oncology Clinic

Ypsilanti, Michigan, 48197, United States

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Minnesota Oncology-Minneapolis

Minneapolis, Minnesota, 55404, United States

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University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

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Washington University

St Louis, Missouri, 63110, United States

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St. Vincent Regional Hospital - West End Clinic

Billings, Montana, 59106, United States

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Methodist Hospital Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

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John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

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Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States

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State University of New York Upstate Medical Unive

Syracuse, New York, 13210, United States

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University of Rochester, James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

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Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242, United States

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The Mark H Zangmeister Cancer Center Ohio

Columbus, Ohio, 43219, United States

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Medical University of South Carolina

Charleston, South Carolina, 29425, United States

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Cancer Care Center of South Texas-Medical Center

San Antonio, Texas, 78229, United States

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Texas Oncology-Tyler

Tyler, Texas, 75702, United States

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Texas Oncology-Austin Center

Austin, Texas, 78731, United States

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Houston Methodist Cancer Center

Houston, Texas, 77030, United States

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Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

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Virginia Cancer Specialists, Pc

Fairfax, Virginia, 22031, United States

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Carilion Clinic

Roanoke, Virginia, 24016-4962, United States

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West Virginia University

Morgantown, West Virginia, 26506, United States

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Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

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Status: Not yet recruiting

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