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

Last updated: May 29, 2026
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cysts

Vaginal Cancer

Ovarian Cancer

Treatment

INCB123667

Clinical Study ID

NCT07023627
INCB123667-203
2025-521513-14-00
OV94
GOG-3129/INCB123667-203
GOG-3129
  • Ages 18-99
  • Female

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 Criteria

Inclusion

Inclusion Criteria:

  • Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, orprimary peritoneal cancer.

  • Have platinum-resistant disease:

  • Participants who have only had 1 line of platinum-based therapy must havereceived at least 4 cycles of a platinum-containing regimen.

  • Participants who have received 2 to 4 lines of platinum-based therapy must haveprogressed on or within 6 months after the last dose of platinum.

  • Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatmentbiopsy is preferred, however an archival sample is acceptable as long as the sampleis no older than 5 years.

  • Received at least 1 and no more than 4 prior lines of systemic therapy following theinitial diagnosis, after which single-agent therapy is considered an appropriatenext 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 mirvetuximabsoravtansine unless there is an exception for its use on medical grounds.

Exclusion

Exclusion Criteria:

  • Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumorscontaining any of these histologies, or low-grade/borderline ovarian cancer.

  • Have primary platinum-refractory disease: either did not respond (CR or PR) tofirst-line platinum-containing therapy or progressed on or within 3 months after thelast dose of the first line platinum-containing therapy.

  • The tumor tests positive for FRα but the participant has not received mirvetuximabsoravtansine for any reason other than medical contraindication.

  • Clinically significant or uncontrolled cardiac disease within 6 months before thefirst 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

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: INCB123667
Phase: 2
Study Start date:
November 12, 2025
Estimated Completion Date:
October 24, 2027

Connect with a study center

  • Blacktown Cancer & Haematology Centre-Blacktown Hospital

    Blacktown, New South Wales 02148
    Australia

    Site Not Available

  • Concord General Repatriation Hospital

    Concord, New South Wales 02139
    Australia

    Site Not Available

  • Burnside War Memorial Hospital - the Brian Fricker Oncology Centre

    Adelaide, South Australia 05065
    Australia

    Active - Recruiting

  • Hobart Hospital-Royal Hobart Hospital

    Hobart, Tasmania 07000
    Australia

    Active - Recruiting

  • Cancer Research Sa (Crsa)

    Adelaide, 05000
    Australia

    Active - Recruiting

  • Cancer Research Sa (Crsa)

    Adelaide 2078025, 05000
    Australia

    Site Not Available

  • Southern Oncology Clinical Research Unit

    South Australia, 05042
    Australia

    Site Not Available

  • Cliniques Universitaires St Luc Ucl

    Brussels, B-1200
    Belgium

    Active - Recruiting

  • Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet

    Brussels, 01070
    Belgium

    Active - Recruiting

  • Cliniques Universitaires St Luc Ucl

    Brussels 2800866, B-1200
    Belgium

    Site Not Available

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

    Brussels 2800866, 01070
    Belgium

    Site Not Available

  • Az Groeninge

    Kortrijk, 08500
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 03000
    Belgium

    Active - Recruiting

  • Chu Liege

    Liège, 04000
    Belgium

    Site Not Available

  • Hyogo Cancer Center

    Akashi-shi, 673-8558
    Japan

    Active - Recruiting

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume, 830-0011
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of Jfcr

    Kōtoku, 135-8550
    Japan

    Active - Recruiting

  • Shikoku Cancer Center

    Matsuyama, 791-0280
    Japan

    Active - Recruiting

  • Shikoku Cancer Center

    Matsuyama 1926099, 791-0280
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, 060-8648
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Sunto-gun, 411-8777
    Japan

    Active - Recruiting

  • Panoncology Trials

    San Juan, PR 00935
    Puerto Rico

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitario Vall D'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Instituto Catalan de Oncologia - Hospital Duran I Reynals

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona (Hospital Clinic I Provincial)

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Hospital Universitario Vall D'Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Institut Catala D'Oncologia Girona

    Girona, 17007
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Sede Madrid

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen de La Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009
    Spain

    Active - Recruiting

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

    Valencia, 46010
    Spain

    Active - Recruiting

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

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona

    Bellinzona, 06500
    Switzerland

    Active - Recruiting

  • Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona

    Bellinzona 2661567, 06500
    Switzerland

    Site Not Available

  • Kantonsspital Graubunden

    Chur, 07000
    Switzerland

    Site Not Available

  • Geneva University Hospitals-Hug

    Geneva, 01211
    Switzerland

    Active - Recruiting

  • Hopital Du Valais-Geneva University Hospitals - Hug

    Geneva 2660646, 01211
    Switzerland

    Site Not Available

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

    Lausanne, 01011
    Switzerland

    Active - Recruiting

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

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital - Imperial College Healthcare Nhs Trust

    London, W12 0HS
    United Kingdom

    Active - Recruiting

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

    London, SM2 5PT
    United Kingdom

    Active - Recruiting

  • St Bartholomew'S Hospital

    London, EC1A 7BE
    United Kingdom

    Site Not Available

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

    London 2643743, SE1 9RT
    United Kingdom

    Site Not Available

  • Hammersmith Hospital - Imperial College Healthcare Nhs Trust

    London 2643743, W12 0HS
    United Kingdom

    Active - Recruiting

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

    London 2643743, SM2 5PT
    United Kingdom

    Site Not Available

  • The Christie Nhs Foundation Trust

    Manchester Greater, M204BX
    United Kingdom

    Active - Recruiting

  • Usa Health Mitchell Cancer Institute

    Mobile, Alabama 36604
    United States

    Active - Recruiting

  • University of California, Los Angeles Medical Center

    Los Angeles, California 90024-6995
    United States

    Active - Recruiting

  • Scripps Healthscripps Mercy Hospital Prebys Cancer Center

    San Diego, California 92103
    United States

    Active - Recruiting

  • Medstar Georgetown University Hospital

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

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • Northeast Georgia Medical Center Gainesville

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Parkview Research Center

    Fort Wayne, Indiana 46845
    United States

    Active - Recruiting

  • Community Health Network, Inc.

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa 52242-1009
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Trials365, Llc

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Trials365, Llc

    Shreveport 4341513, Louisiana 4331987 71133
    United States

    Site Not Available

  • Greater Baltimore Medical Center

    Baltimore, Maryland 21204
    United States

    Active - Recruiting

  • John Hopkins University-School of Medicine

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Greater Baltimore Medical Center

    Baltimore 4347778, Maryland 4361885 21204
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Umass Memorial Medical Center, Inc.

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • University of Michigan Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Minnesota Oncology-Minneapolis

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Washington University

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • St. Vincent Regional Hospital - West End Clinic

    Billings, Montana 59106
    United States

    Active - Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • John Theurer Cancer Center, Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York 10016
    United States

    Active - Recruiting

  • University of Rochester, James P. Wilmot Cancer Center

    Rochester, New York 14642
    United States

    Site Not Available

  • State University of New York Upstate Medical Unive

    Syracuse, New York 13210
    United States

    Site Not Available

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • The Mark H Zangmeister Cancer Center Ohio

    Columbus, Ohio 43219
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

    Hilliard, Ohio 43026
    United States

    Active - Recruiting

  • Penn State College of Medicine

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Asplundh Cancer Pavilion - Thomas Jefferson

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Texas Oncology-Austin Center

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Houston Methodist Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Cancer Care Center of South Texas-Medical Center

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Texas Oncology-San Antonio Medical Center Pharmacy

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Texas Oncology-Tyler

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah 84106
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, Pc

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Carilion Clinic

    Roanoke, Virginia 24016-4962
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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