RecruitingPhase 2NCT07023627

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

A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)

Sponsor

Incyte Corporation

Enrollment

160 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

Summary

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called INCB123667 in women with ovarian cancer that has stopped responding to platinum-based chemotherapy (platinum-resistant) and whose tumors have a specific protein overexpression called Cyclin E1. **You may be eligible if...** - You have been diagnosed with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer - Your cancer is platinum-resistant (came back within 6 months of platinum treatment, or you had only one platinum course and received at least 4 cycles) - You have received at least 1 but no more than 4 prior lines of treatment - You are willing to undergo a biopsy before starting treatment (or have recent archival tissue available) - You previously received bevacizumab (unless there was a medical reason you could not) **You may NOT be eligible if...** - Your ovarian cancer is a specific non-serous subtype (clear cell, endometrioid, mucinous, or sarcomatous) - You have not received required prior standard treatments - You have active brain metastases or other serious conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINCB123667

Administered orally twice daily (BID).

Locations(81)

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

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 Cancer Center

Ann Arbor, Michigan, 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

Nebraska Methodist Hospital

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

The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

Hilliard, Ohio, United States

Penn State College of Medicine

Hershey, Pennsylvania, United States

Asplundh Cancer Pavilion - Thomas Jefferson

Willow Grove, 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

Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet

Brussels, Belgium

Cliniques Universitaires St Luc Ucl

Brussels, Belgium

Az Groeninge

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

Barcelona, Spain

Instituto Catalan de Oncologia - Hospital Duran I Reynals

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, 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

Fundacion Instituto Valenciano de Oncologia

Valencia, Spain

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

Valencia, Spain

Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona

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

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

View Full Details on ClinicalTrials.gov

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NCT07023627

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