RecruitingInterventionalPhase 2

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

NCT ID: NCT07023627Sponsor: Incyte CorporationLast updated: 2026-06-01

Summary

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

Arms & interventions

DrugINCB123667
Administered orally twice daily (BID).

Outcome measures

Primary

Objective Response by IRC
Defined as having a confirmed best overall response of complete response (CR) or partial response (PR), as determined by independent review committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 2 years

Secondary

Duration of Response (DOR) by IRC
Time frame: Up to 2 years
Progression-Free Survival (PFS) by IRC
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Objective Response by Investigator
Time frame: Up to 2 years
DOR by investigator
Time frame: Up to 2 years
PFS by Investigator
Time frame: Up to 2 years
Treatment Emergent Adverse Events (TEAE'S)
Time frame: Up to 2 years and 30 days
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Time frame: Up to 2 years and 30 days

Eligibility criteria

Sex: FemaleAge: 18 Years to 99 YearsHealthy volunteers: No

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 locations (42)

Usa Health Mitchell Cancer Institute

Mobile, Alabama, 36604

Recruiting

University of California, Los Angeles Medical Center

Los Angeles, California, 90024-6995

Recruiting

Scripps Healthscripps Mercy Hospital Prebys Cancer Center

San Diego, California, 92103

Recruiting

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20010

Recruiting

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33901

Recruiting

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Recruiting

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

Recruiting

Florida Cancer Specialists & Research Institute

West Palm Beach, Florida, 33401

Recruiting

Northeast Georgia Medical Center Gainesville

Gainesville, Georgia, 30501

Recruiting

Parkview Research Center

Fort Wayne, Indiana, 46845

Recruiting

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

Withdrawn

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242-1009

Recruiting

Norton Cancer Institute

Louisville, Kentucky, 40207

Recruiting

Trials365, Llc

Shreveport, Louisiana, 71103

Recruiting

Greater Baltimore Medical Center

Baltimore, Maryland, 21204

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Umass Memorial Medical Center, Inc.

Worcester, Massachusetts, 01605

Not Yet Recruiting

University of Michigan Health System

Ann Arbor, Michigan, 48109

Not Yet Recruiting

Minnesota Oncology-Minneapolis

Minneapolis, Minnesota, 55404

Recruiting

University of Mississippi Medical Center

Jackson, Mississippi, 39216

Not Yet Recruiting

Washington University

St Louis, Missouri, 63110

Recruiting

St. Vincent Regional Hospital - West End Clinic

Billings, Montana, 59106

Recruiting

Nebraska Methodist Hospital

Omaha, Nebraska, 68114

Recruiting

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting

Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016

Recruiting

University of Rochester, James P. Wilmot Cancer Center

Rochester, New York, 14642

Withdrawn

State University of New York Upstate Medical Unive

Syracuse, New York, 13210

Not Yet Recruiting

Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242

Recruiting

The Mark H Zangmeister Cancer Center Ohio

Columbus, Ohio, 43219

Recruiting

The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

Hilliard, Ohio, 43026

Recruiting

Penn State College of Medicine

Hershey, Pennsylvania, 17033

Not Yet Recruiting

Asplundh Cancer Pavilion - Thomas Jefferson

Willow Grove, Pennsylvania, 19090

Withdrawn

Medical University of South Carolina

Charleston, South Carolina, 29425

Not Yet Recruiting

Texas Oncology-Austin Center

Austin, Texas, 78731

Recruiting

Houston Methodist Cancer Center

Houston, Texas, 77030

Withdrawn

Texas Oncology-San Antonio Medical Center Pharmacy

San Antonio, Texas, 78229

Recruiting

Texas Oncology-Tyler

Tyler, Texas, 75702

Recruiting

Utah Cancer Specialists

Salt Lake City, Utah, 84106

Recruiting

Virginia Cancer Specialists

Fairfax, Virginia, 22031

Recruiting

Carilion Clinic

Roanoke, Virginia, 24016-4962

Recruiting

West Virginia University

Morgantown, West Virginia, 26506

Recruiting

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Not Yet Recruiting