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

NCT07023627 · Incyte Corporation
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Official title
A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)
About this study
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 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 target: 160 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-12
Estimated completion: 2027-10-24
Last updated: 2026-04-14
Interventions
Drug: INCB123667
Primary outcomes
  • Objective Response by IRC (Up to 2 years)
Sponsor
Incyte Corporation · industry
With: ENGOT Foundation, GOG Foundation
Contacts & investigators
ContactIncyte Corporation Call Center (US) · contact · medinfo@incyte.com · 1.855.463.3463
ContactIncyte Corporation Call Center (ex-US) · contact · eumedinfo@incyte.com · +800 00027423
InvestigatorIncyte Medical Monitor · study_director, Incyte Corporation
All locations (81)
Usa Health Mitchell Cancer InstituteNot Yet Recruiting
Mobile, Alabama, United States
Uams Winthrop P Rockefeller Cancer InstituteNot Yet Recruiting
Little Rock, Arkansas, United States
University of California, Los Angeles Medical CenterRecruiting
Los Angeles, California, United States
Scripps Healthscripps Mercy Hospital Prebys Cancer CenterRecruiting
San Diego, California, United States
Medstar Georgetown University HospitalNot Yet Recruiting
Washington D.C., District of Columbia, United States
Florida Cancer Specialists & Research InstituteRecruiting
Fort Myers, Florida, United States
Mayo ClinicWithdrawn
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer CenterNot Yet Recruiting
Miami, Florida, United States
Mount Sinai Comprehensive Cancer CenterRecruiting
Miami Beach, Florida, United States
Florida Cancer Specialists & Research InstituteRecruiting
West Palm Beach, Florida, United States
Northeast Georgia Medical Center GainesvilleRecruiting
Gainesville, Georgia, United States
Parkview Research CenterRecruiting
Fort Wayne, Indiana, United States
University of Iowa Hospital and ClinicsNot Yet Recruiting
Iowa City, Iowa, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
Trials365, LlcRecruiting
Shreveport, Louisiana, United States
Greater Baltimore Medical CenterRecruiting
Baltimore, Maryland, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Umass Memorial Medical Center, Inc.Not Yet Recruiting
Worcester, Massachusetts, United States
University of Michigan Cancer CenterWithdrawn
Ann Arbor, Michigan, United States
University of Michigan Health SystemNot Yet Recruiting
Ann Arbor, Michigan, United States
Minnesota Oncology-MinneapolisRecruiting
Minneapolis, Minnesota, United States
University of Mississippi Medical CenterNot Yet Recruiting
Jackson, Mississippi, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
St. Vincent Regional Hospital - West End ClinicRecruiting
Billings, Montana, United States
Nebraska Methodist HospitalRecruiting
Omaha, Nebraska, United States
John Theurer Cancer Center, Hackensack University Medical CenterNot Yet Recruiting
Hackensack, New Jersey, United States
Laura and Isaac Perlmutter Cancer CenterRecruiting
New York, New York, United States
University of Rochester, James P. Wilmot Cancer CenterWithdrawn
Rochester, New York, United States
State University of New York Upstate Medical UniveNot Yet Recruiting
Syracuse, New York, United States
Oncology Hematology Care, IncRecruiting
Cincinnati, Ohio, United States
The Mark H Zangmeister Cancer Center OhioRecruiting
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center Division of Gynecologic OncologyNot Yet Recruiting
Hilliard, Ohio, United States
Penn State College of MedicineNot Yet Recruiting
Hershey, Pennsylvania, United States
Asplundh Cancer Pavilion - Thomas JeffersonWithdrawn
Willow Grove, Pennsylvania, United States
Medical University of South CarolinaNot Yet Recruiting
Charleston, South Carolina, United States
Texas Oncology-Austin CenterRecruiting
Austin, Texas, United States
Houston Methodist Cancer CenterWithdrawn
Houston, Texas, United States
Cancer Care Center of South Texas-Medical CenterRecruiting
San Antonio, Texas, United States
Texas Oncology-TylerRecruiting
Tyler, Texas, United States
Utah Cancer SpecialistsNot Yet Recruiting
Salt Lake City, Utah, United States
Virginia Cancer Specialists, PcRecruiting
Fairfax, Virginia, United States
Carilion ClinicRecruiting
Roanoke, Virginia, United States
West Virginia UniversityRecruiting
Morgantown, West Virginia, United States
Froedtert & the Medical College of WisconsinNot Yet Recruiting
Milwaukee, Wisconsin, United States
Blacktown Cancer & Haematology Centre-Blacktown HospitalNot Yet Recruiting
Blacktown, New South Wales, Australia
Concord General Repatriation HospitalNot Yet Recruiting
Concord, New South Wales, Australia
Burnside War Memorial Hospital - the Brian Fricker Oncology CentreNot Yet Recruiting
Adelaide, South Australia, Australia
Hobart Hospital-Royal Hobart HospitalNot Yet Recruiting
Hobart, Tasmania, Australia
Cancer Research Sa (Crsa)Not Yet Recruiting
Adelaide, Australia
Hopital Universitaire de Bruxelles (Hub) - Institut Jules BordetRecruiting
Brussels, Belgium
Cliniques Universitaires St Luc UclRecruiting
Brussels, Belgium
Az GroeningeRecruiting
Kortrijk, Belgium
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Belgium
Chu LiegeNot Yet Recruiting
Liège, Belgium
Hyogo Cancer CenterRecruiting
Akashi-shi, Japan
Saitama Medical University International Medical CenterRecruiting
Hidaka-shi, Japan
The Cancer Institute Hospital of JfcrRecruiting
Kōtoku, Japan
Kurume University HospitalRecruiting
Kurume, Japan
Shikoku Cancer CenterRecruiting
Matsuyama, Japan
Hokkaido University HospitalRecruiting
Sapporo, Japan
Shizuoka Cancer CenterRecruiting
Sunto-gun, Japan
Panoncology TrialsRecruiting
San Juan, PR, Puerto Rico
Hospital Universitario Vall D'HebronNot Yet Recruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Instituto Catalan de Oncologia - Hospital Duran I ReynalsNot Yet Recruiting
Barcelona, Spain
Hospital Universitario Reina SofiaNot Yet Recruiting
Córdoba, Spain
Institut Catala D'Oncologia GironaRecruiting
Girona, Spain
Clinica Universidad de Navarra - Sede MadridRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario Virgen de La ArrixacaRecruiting
Murcia, Spain
Fundacion Instituto Valenciano de OncologiaRecruiting
Valencia, Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)Not Yet Recruiting
Valencia, Spain
Istituto Oncologico Della Svizzera Italiana (Iosi) Di BellinzonaNot Yet Recruiting
Bellinzona, Switzerland
Kantonsspital GraubundenNot Yet Recruiting
Chur, Switzerland
Geneva University Hospitals-HugNot Yet Recruiting
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment HospitNot Yet Recruiting
Lausanne, Switzerland
St Bartholomew'S HospitalNot Yet Recruiting
London, United Kingdom
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation TrustRecruiting
London, United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation TrustRecruiting
London, United Kingdom
Hammersmith Hospital - Imperial College Healthcare Nhs TrustRecruiting
London, United Kingdom
The Christie Nhs Foundation TrustRecruiting
Manchester Greater, United Kingdom
A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression · TrialPath