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New hope for hard-to-treat ovarian cancer: experimental drug targets key protein

NCT ID NCT07023627

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 8 times

Summary

This study tests a new drug called INCB123667 in 160 people with a type of ovarian cancer that no longer responds to platinum chemotherapy and has high levels of a protein called cyclin E1. The goal is to see if the drug can shrink tumors or slow the cancer's growth. Participants will receive the drug and be monitored for safety and how well it works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube serous adenocarcinoma ovarian cancer ovarian carcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    74 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Az Groeninge

    RECRUITING

    Kortrijk, 08500, Belgium

  • Blacktown Cancer & Haematology Centre-Blacktown Hospital

    RECRUITING

    Blacktown, New South Wales, 02148, Australia

  • Burnside War Memorial Hospital - the Brian Fricker Oncology Centre

    RECRUITING

    Adelaide, South Australia, 05065, Australia

  • Cancer Research Sa (Crsa)

    RECRUITING

    Adelaide, 05000, Australia

  • Carilion Clinic

    RECRUITING

    Roanoke, Virginia, 24016-4962, United States

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

    RECRUITING

    Lausanne, 01011, Switzerland

  • Chu Liege

    RECRUITING

    Liège, 04000, Belgium

  • Clinica Universidad de Navarra - Sede Madrid

    RECRUITING

    Madrid, 28027, Spain

  • Cliniques Universitaires St Luc Ucl

    RECRUITING

    Brussels, B-1200, Belgium

  • Concord General Repatriation Hospital

    RECRUITING

    Concord, New South Wales, 02139, Australia

  • Florida Cancer Specialists & Research Institute

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • Florida Cancer Specialists & Research Institute

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Froedtert & the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Fundacion Instituto Valenciano de Oncologia

    RECRUITING

    Valencia, 46009, Spain

  • Geneva University Hospitals-Hug

    RECRUITING

    Geneva, 01211, Switzerland

  • Greater Baltimore Medical Center

    RECRUITING

    Baltimore, Maryland, 21204, United States

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

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Hammersmith Hospital - Imperial College Healthcare Nhs Trust

    RECRUITING

    London, W12 0HS, United Kingdom

  • Hobart Hospital-Royal Hobart Hospital

    RECRUITING

    Hobart, Tasmania, 07000, Australia

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, 060-8648, Japan

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

    RECRUITING

    Brussels, 01070, Belgium

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

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

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitario Vall D'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de La Arrixaca

    RECRUITING

    Murcia, 30120, Spain

  • Hyogo Cancer Center

    RECRUITING

    Akashi-shi, 673-8558, Japan

  • Institut Catala D'Oncologia Girona

    RECRUITING

    Girona, 17007, Spain

  • Instituto Catalan de Oncologia - Hospital Duran I Reynals

    RECRUITING

    Barcelona, 08908, Spain

  • Istituto Oncologico Della Svizzera Italiana (Iosi) Di Bellinzona

    RECRUITING

    Bellinzona, 06500, Switzerland

  • John Theurer Cancer Center, Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kantonsspital Graubunden

    RECRUITING

    Chur, 07000, Switzerland

  • Kurume University Hospital

    RECRUITING

    Kurume, 830-0011, Japan

  • Laura and Isaac Perlmutter Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medstar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Minnesota Oncology-Minneapolis

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Mount Sinai Comprehensive Cancer Center

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • Nebraska Methodist Hospital

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Northeast Georgia Medical Center Gainesville

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Oncology Hematology Care, Inc

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Panoncology Trials

    RECRUITING

    San Juan, PR, 00935, Puerto Rico

  • Parkview Research Center

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Penn State College of Medicine

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

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

    RECRUITING

    London, SM2 5PT, United Kingdom

  • Saitama Medical University International Medical Center

    RECRUITING

    Hidaka-shi, 350-1298, Japan

  • Scripps Healthscripps Mercy Hospital Prebys Cancer Center

    RECRUITING

    San Diego, California, 92103, United States

  • Shikoku Cancer Center

    RECRUITING

    Matsuyama, 791-0280, Japan

  • Shizuoka Cancer Center

    RECRUITING

    Sunto-gun, 411-8777, Japan

  • St. Vincent Regional Hospital - West End Clinic

    RECRUITING

    Billings, Montana, 59106, United States

  • State University of New York Upstate Medical Unive

    RECRUITING

    Syracuse, New York, 13210, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • Texas Oncology-Austin Center

    RECRUITING

    Austin, Texas, 78731, United States

  • Texas Oncology-San Antonio Medical Center Pharmacy

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Texas Oncology-Tyler

    RECRUITING

    Tyler, Texas, 75702, United States

  • The Cancer Institute Hospital of Jfcr

    RECRUITING

    Kōtoku, 135-8550, Japan

  • The Christie Nhs Foundation Trust

    RECRUITING

    Manchester Greater, M204BX, United Kingdom

  • The Mark H Zangmeister Cancer Center Ohio

    RECRUITING

    Columbus, Ohio, 43219, United States

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

    RECRUITING

    Hilliard, Ohio, 43026, United States

  • Trials365, Llc

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Umass Memorial Medical Center, Inc.

    RECRUITING

    Worcester, Massachusetts, 01605, United States

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 03000, Belgium

  • University of California, Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90024-6995, United States

  • University of Iowa Hospital and Clinics

    RECRUITING

    Iowa City, Iowa, 52242-1009, United States

  • University of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • Usa Health Mitchell Cancer Institute

    RECRUITING

    Mobile, Alabama, 36604, United States

  • Utah Cancer Specialists

    RECRUITING

    Salt Lake City, Utah, 84106, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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