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

RecruitingPhase 2

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

Who can join

Ages 18 to 99 · Women

Full 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.

About the study

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

What is being tested

Sponsor: Incyte Corporation · Participants: 160 · Started: Nov 12, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07023627

Locations in the U.S.

AlabamaUsa Health Mitchell Cancer Institute, Mobile
CaliforniaUniversity of California, Los Angeles Medical Center, Los Angeles
Scripps Healthscripps Mercy Hospital Prebys Cancer Center, San Diego
District of ColumbiaMedstar Georgetown University Hospital, Washington D.C.
FloridaFlorida Cancer Specialists & Research Institute, Fort Myers
Sylvester Comprehensive Cancer Center, Miami
Mount Sinai Comprehensive Cancer Center, Miami Beach
Florida Cancer Specialists & Research Institute, West Palm Beach
GeorgiaNortheast Georgia Medical Center Gainesville, Gainesville
IndianaParkview Research Center, Fort Wayne
IowaUniversity of Iowa Hospital and Clinics, Iowa City
KentuckyNorton Cancer Institute, Louisville
LouisianaTrials365, Llc, Shreveport
MarylandGreater Baltimore Medical Center, Baltimore
MassachusettsMassachusetts General Hospital, Boston
Umass Memorial Medical Center, Inc., Worcester
MichiganUniversity of Michigan Health System, Ann Arbor
MinnesotaMinnesota Oncology-Minneapolis, Minneapolis
MississippiUniversity of Mississippi Medical Center, Jackson
MissouriWashington University, St Louis
MontanaSt. Vincent Regional Hospital - West End Clinic, Billings
NebraskaNebraska Methodist Hospital, Omaha
New JerseyJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack
New YorkLaura and Isaac Perlmutter Cancer Center, New York
State University of New York Upstate Medical Unive, Syracuse
OhioOncology Hematology Care, Inc, Cincinnati
The Mark H Zangmeister Cancer Center Ohio, Columbus
The Ohio State University Wexner Medical Center Division of Gynecologic Oncology, Hilliard
PennsylvaniaPenn State College of Medicine, Hershey
South CarolinaMedical University of South Carolina, Charleston
TexasTexas Oncology-Austin Center, Austin
Texas Oncology-San Antonio Medical Center Pharmacy, San Antonio
Texas Oncology-Tyler, Tyler
UtahUtah Cancer Specialists, Salt Lake City
VirginiaVirginia Cancer Specialists, Fairfax
Carilion Clinic, Roanoke
West VirginiaWest Virginia University, Morgantown
WisconsinFroedtert & the Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.