A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
NCT ID: NCT07023627
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2025-11-15
2027-10-24
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
INCB123667
Administered orally twice daily (BID).
Cohort 2
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
INCB123667
Administered orally twice daily (BID).
Cohort 3
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
INCB123667
Administered orally twice daily (BID).
Interventions
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INCB123667
Administered orally twice daily (BID).
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
99 Years
FEMALE
No
Sponsors
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ENGOT Foundation
UNKNOWN
GOG Foundation
NETWORK
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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John Hopkins University-School of Medicine
Baltimore, Maryland, United States
Usa Health Mitchell Cancer Institute
Mobile, Alabama, United States
Uams Winthrop P Rockefeller Cancer Institute
Little Rock, Arkansas, United States
University of California, Los Angeles Medical Center
Los Angeles, California, United States
Scripps Healthscripps Mercy Hospital Prebys Cancer Center
San Diego, California, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Florida Cancer Specialists & Research Institute
West Palm Beach, Florida, United States
Northeast Georgia Medical Center Gainesville
Gainesville, Georgia, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Trials365, Llc
Shreveport, Louisiana, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Umass Memorial Medical Center, Inc.
Worcester, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Minnesota Oncology-Minneapolis
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University
St Louis, Missouri, United States
St. Vincent Regional Hospital - West End Clinic
Billings, Montana, United States
Methodist Hospital Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, United States
State University of New York Upstate Medical Unive
Syracuse, New York, United States
Oncology Hematology Care, Inc
Cincinnati, Ohio, United States
The Mark H Zangmeister Cancer Center Ohio
Columbus, Ohio, United States
Penn State College of Medicine
Hershey, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Oncology-Austin Center
Austin, Texas, United States
Houston Methodist Cancer Center
Houston, Texas, United States
Cancer Care Center of South Texas-Medical Center
San Antonio, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Virginia Cancer Specialists, Pc
Fairfax, Virginia, United States
Carilion Clinic
Roanoke, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Blacktown Cancer & Haematology Centre-Blacktown Hospital
Blacktown, New South Wales, Australia
Concord General Repatriation Hospital
Concord, New South Wales, Australia
Burnside War Memorial Hospital - the Brian Fricker Oncology Centre
Adelaide, South Australia, Australia
Hobart Hospital-Royal Hobart Hospital
Hobart, Tasmania, Australia
Cancer Research Sa (Crsa)
Adelaide, , Australia
Southern Oncology Clinical Research Unit
South Australia, , Australia
Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)
Brussels, , Belgium
Cliniques Universitaires St Luc Ucl
Brussels, , Belgium
Az Groeninge Campus Kennedylaan
Kortrijk, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Chu Liege
Liège, , Belgium
Hyogo Cancer Center
Akashi-shi, , Japan
Saitama Medical University International Medical Center
Hidaka-shi, , Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, , Japan
Kurume University Hospital
Kurume, , Japan
Shikoku Cancer Center
Matsuyama, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Shizuoka Cancer Center
Sunto-gun, , Japan
Panoncology Trials
San Juan, PR, Puerto Rico
Hospital Universitario Vall D'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona (Hospital Clinic I Provincial)
Barcelona, , Spain
Instituto Catalan de Oncologia - Hospital Duran I Reynals
Barcelona, , Spain
Institut Catala D'Oncologia Girona
Girona, , Spain
Clinica Universidad de Navarra - Sede Madrid
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen de La Arrixaca
Murcia, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)
Valencia, , Spain
Istituto Oncologico Della Svizzera Italiana
Bellinzona, , Switzerland
Kantonsspital Graubunden
Chur, , Switzerland
Geneva University Hospitals-Hug
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit
Lausanne, , Switzerland
Kantonsspital Baselland (Ksbl) - Standort Liestal - Medizinische Universitatsklinik
Liestal, , Switzerland
Western General Hospital - Lothian Health Board
Edinburgh, , United Kingdom
St Bartholomew'S Hospital
London, , United Kingdom
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, , United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust
London, , United Kingdom
Hammersmith Hospital - Imperial College Healthcare Nhs Trust
London, , United Kingdom
The Christie Nhs Foundation Trust
Manchester Greater, , United Kingdom
Countries
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Central Contacts
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Related Links
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A study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Other Identifiers
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GOG-3129
Identifier Type: OTHER
Identifier Source: secondary_id
2025-521513-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
OV94
Identifier Type: OTHER
Identifier Source: secondary_id
INCB123667-203
Identifier Type: -
Identifier Source: org_study_id