A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
MAESTRA 1
A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)
4 other identifiers
interventional
160
8 countries
79
Brief Summary
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Nov 2025
Shorter than P25 for phase_2 ovarian-cancer
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2025
CompletedFirst Posted
Study publicly available on registry
June 17, 2025
CompletedStudy Start
First participant enrolled
November 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 24, 2027
June 1, 2026
May 1, 2026
1.5 years
June 9, 2025
May 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 2 years
Secondary Outcomes (8)
Duration of Response (DOR) by IRC
Up to 2 years
Progression-Free Survival (PFS) by IRC
Up to 2 years
Overall Survival (OS)
Up to 2 years
Objective Response by Investigator
Up to 2 years
DOR by investigator
Up to 2 years
- +3 more secondary outcomes
Study Arms (3)
Cohort 1
EXPERIMENTALINCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Cohort 2
EXPERIMENTALINCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Cohort 3
EXPERIMENTALINCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GOG Foundationcollaborator
- ENGOT Foundationcollaborator
- Incyte Corporationlead
Study Sites (79)
Usa Health Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
University of California, Los Angeles Medical Center
Los Angeles, California, 90024-6995, United States
Scripps Healthscripps Mercy Hospital Prebys Cancer Center
San Diego, California, 92103, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20010, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33901, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Florida Cancer Specialists & Research Institute
West Palm Beach, Florida, 33401, United States
Northeast Georgia Medical Center Gainesville
Gainesville, Georgia, 30501, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242-1009, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Trials365, Llc
Shreveport, Louisiana, 71103, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Umass Memorial Medical Center, Inc.
Worcester, Massachusetts, 01605, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Minnesota Oncology-Minneapolis
Minneapolis, Minnesota, 55404, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Washington University
St Louis, Missouri, 63110, United States
St. Vincent Regional Hospital - West End Clinic
Billings, Montana, 59106, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016, United States
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
State University of New York Upstate Medical Unive
Syracuse, New York, 13210, United States
Oncology Hematology Care, Inc
Cincinnati, Ohio, 45242, United States
The Mark H Zangmeister Cancer Center Ohio
Columbus, Ohio, 43219, United States
The Ohio State University Wexner Medical Center Division of Gynecologic Oncology
Hilliard, Ohio, 43026, United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
Asplundh Cancer Pavilion - Thomas Jefferson
Willow Grove, Pennsylvania, 19090, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Oncology-Austin Center
Austin, Texas, 78731, United States
Houston Methodist Cancer Center
Houston, Texas, 77030, United States
Texas Oncology-San Antonio Medical Center Pharmacy
San Antonio, Texas, 78229, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Carilion Clinic
Roanoke, Virginia, 24016-4962, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Blacktown Cancer & Haematology Centre-Blacktown Hospital
Blacktown, New South Wales, 02148, Australia
Concord General Repatriation Hospital
Concord, New South Wales, 02139, Australia
Burnside War Memorial Hospital - the Brian Fricker Oncology Centre
Adelaide, South Australia, 05065, Australia
Hobart Hospital-Royal Hobart Hospital
Hobart, Tasmania, 07000, Australia
Cancer Research Sa (Crsa)
Adelaide, 05000, Australia
Southern Oncology Clinical Research Unit
South Australia, 05042, Australia
Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet
Brussels, 01070, Belgium
Cliniques Universitaires St Luc Ucl
Brussels, B-1200, Belgium
Az Groeninge
Kortrijk, 08500, Belgium
Universitair Ziekenhuis Leuven
Leuven, 03000, Belgium
Chu Liege
Liège, 04000, Belgium
Hyogo Cancer Center
Akashi-shi, 673-8558, Japan
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298, Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Shizuoka Cancer Center
Sunto-gun, 411-8777, Japan
Panoncology Trials
San Juan, PR, 00935, Puerto Rico
Hospital Universitario Vall D'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Instituto Catalan de Oncologia - Hospital Duran I Reynals
Barcelona, 08908, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Institut Catala D'Oncologia Girona
Girona, 17007, Spain
Clinica Universidad de Navarra - Sede Madrid
Madrid, 28027, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen de La Arrixaca
Murcia, 30120, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)
Valencia, 46010, Spain
Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona
Bellinzona, 06500, Switzerland
Kantonsspital Graubunden
Chur, 07000, Switzerland
Geneva University Hospitals-Hug
Geneva, 01211, Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit
Lausanne, 01011, Switzerland
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, SE1 9RT, United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust
London, SM2 5PT, United Kingdom
Hammersmith Hospital - Imperial College Healthcare Nhs Trust
London, W12 0HS, United Kingdom
The Christie Nhs Foundation Trust
Manchester Greater, M204BX, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Incyte Medical Monitor
Incyte Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2025
First Posted
June 17, 2025
Study Start
November 12, 2025
Primary Completion (Estimated)
April 27, 2027
Study Completion (Estimated)
October 24, 2027
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- Access Criteria
- Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency