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Ovarian CancerPhase 2MAESTRA 1NCT07023627

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

A Phase 2 study testing INCB123667 in people with Ovarian Cancer, run by Incyte Corporation at 74 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
INCB123667
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
74 sitesin 8 countries
Study dates
12 Nov 2025to 24 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

74 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Incyte Corporation Call Center (US) contact

1.855.463.3463

medinfo@incyte.com

Incyte Corporation Call Center (ex-US) contact

+800 00027423

eumedinfo@incyte.com

74 sites in 8 countries

United States38 sites, 38 recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

    Recruiting

  • Texas Oncology-Austin Center

    Austin, Texas, 78731

    Recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Recruiting

  • St. Vincent Regional Hospital - West End Clinic

    Billings, Montana, 59106

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45242

    Recruiting

  • The Mark H Zangmeister Cancer Center Ohio

    Columbus, Ohio, 43219

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33901

    Recruiting

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

    Recruiting

  • Northeast Georgia Medical Center Gainesville

    Gainesville, Georgia, 30501

    Recruiting

  • John Theurer Cancer Center, Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033

    Recruiting

  • The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

    Hilliard, Ohio, 43026

    Recruiting

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242-1009

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Recruiting

  • University of California, Los Angeles Medical Center

    Los Angeles, California, 90024-6995

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

    Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

    Recruiting

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Minnesota Oncology-Minneapolis

    Minneapolis, Minnesota, 55404

    Recruiting

  • Usa Health Mitchell Cancer Institute

    Mobile, Alabama, 36604

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Recruiting

  • Carilion Clinic

    Roanoke, Virginia, 24016-4962

    Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

    Recruiting

  • Texas Oncology-San Antonio Medical Center Pharmacy

    San Antonio, Texas, 78229

    Recruiting

  • Scripps Healthscripps Mercy Hospital Prebys Cancer Center

    San Diego, California, 92103

    Recruiting

  • Trials365, Llc

    Shreveport, Louisiana, 71103

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Recruiting

  • State University of New York Upstate Medical Unive

    Syracuse, New York, 13210

    Recruiting

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

    Recruiting

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20010

    Recruiting

  • Florida Cancer Specialists & Research Institute

    West Palm Beach, Florida, 33401

    Recruiting

  • Umass Memorial Medical Center, Inc.

    Worcester, Massachusetts, 01605

    Recruiting

Other trials in United States

Spain10 sites, 10 recruiting

  • Hospital Universitario Vall D'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Instituto Catalan de Oncologia - Hospital Duran I Reynals

    Barcelona, 08908

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

    Recruiting

  • Institut Catala D'Oncologia Girona

    Girona, 17007

    Recruiting

  • Clinica Universidad de Navarra - Sede Madrid

    Madrid, 28027

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Universitario Virgen de La Arrixaca

    Murcia, 30120

    Recruiting

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

    Recruiting

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

    Valencia, 46010

    Recruiting

Other trials in Spain

Japan7 sites, 7 recruiting

  • Hyogo Cancer Center

    Akashi-shi, 673-8558

    Recruiting

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298

    Recruiting

  • The Cancer Institute Hospital of Jfcr

    Kōtoku, 135-8550

    Recruiting

  • Kurume University Hospital

    Kurume, 830-0011

    Recruiting

  • Shikoku Cancer Center

    Matsuyama, 791-0280

    Recruiting

  • Hokkaido University Hospital

    Sapporo, 060-8648

    Recruiting

  • Shizuoka Cancer Center

    Sunto-gun, 411-8777

    Recruiting

Other trials in Japan

Australia5 sites, 5 recruiting

  • Burnside War Memorial Hospital - the Brian Fricker Oncology Centre

    Adelaide, South Australia, 05065

    Recruiting

  • Cancer Research Sa (Crsa)

    Adelaide, 05000

    Recruiting

  • Blacktown Cancer & Haematology Centre-Blacktown Hospital

    Blacktown, New South Wales, 02148

    Recruiting

  • Concord General Repatriation Hospital

    Concord, New South Wales, 02139

    Recruiting

  • Hobart Hospital-Royal Hobart Hospital

    Hobart, Tasmania, 07000

    Recruiting

Other trials in Australia

Belgium5 sites, 5 recruiting

  • Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet

    Brussels, 01070

    Recruiting

  • Cliniques Universitaires St Luc Ucl

    Brussels, B-1200

    Recruiting

  • Az Groeninge

    Kortrijk, 08500

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 03000

    Recruiting

  • Chu Liege

    Liège, 04000

    Recruiting

Other trials in Belgium

Switzerland4 sites, 4 recruiting

  • Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona

    Bellinzona, 06500

    Recruiting

  • Kantonsspital Graubunden

    Chur, 07000

    Recruiting

  • Geneva University Hospitals-Hug

    Geneva, 01211

    Recruiting

  • Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit

    Lausanne, 01011

    Recruiting

Other trials in Switzerland

United Kingdom4 sites, 4 recruiting

  • Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

    London, SE1 9RT

    Recruiting

  • Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust

    London, SM2 5PT

    Recruiting

  • Hammersmith Hospital - Imperial College Healthcare Nhs Trust

    London, W12 0HS

    Recruiting

  • The Christie Nhs Foundation Trust

    Manchester Greater, M204BX

    Recruiting

Other trials in United Kingdom

Puerto Rico1 site, 1 recruiting

  • Panoncology Trials

    San Juan, PR, 00935

    Recruiting

Other trials in Puerto Rico

About this study

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

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

Conditions
Ovarian Cancer
Being tested
INCB123667
Keywords
INCB123667
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCB123667Drug

    Administered orally twice daily (BID).

Study groups in NCT07023627
Study groupRoleWhat they receive
Cohort 1ExperimentalINCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Receives: Drug: INCB123667
Cohort 2ExperimentalINCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Receives: Drug: INCB123667
Cohort 3ExperimentalINCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
Receives: Drug: INCB123667

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 2 years

Secondary outcomes (8)

  1. Duration of Response (DOR) by IRC

    Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  2. Progression-Free Survival (PFS) by IRC

    Defined as the time from the date of first dose of study drug until the earliest date of disease progression as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  3. Overall Survival (OS)

    Defined as the time from the date of first dose of study drug until death due to any cause.

    Measured: Up to 2 years

  4. Objective Response by Investigator

    Defined as having a confirmed best overall response of CR or PR, as determined by investigator assessment per RECIST v1.1.

    Measured: Up to 2 years

  5. DOR by investigator

    Defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  6. PFS by Investigator

    Defined as the time from the date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  7. Treatment Emergent Adverse Events (TEAE'S)

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.

    Measured: Up to 2 years and 30 days

  8. TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment

    TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.

    Measured: Up to 2 years and 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start12 Nov 2025
  3. Primary completion27 Apr 2027 (estimated)
  4. Study completion24 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07023627
Sponsor's protocol ID
INCB123667-203
Other IDs
GOG-3129, 2025-521513-14-00, OV94, 2025
Acronym
MAESTRA 1
Status last verified
Sep 2026
First submitted
9 Jun 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INCB123667 in people with Ovarian Cancer, run by Incyte Corporation at 74 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Spain, Japan, Australia, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response by IRC (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07023627.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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