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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment160 people
  • Recruiting US sites38
  • SponsorIncyte Corporation
  • RegistryNCT07023627

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression: a one-minute explainerNCT070236271 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to 99 Years
  • SexFemale
  • Healthy volunteersNo

You may be able to join 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 cannot join 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.
  • Other protocol-defined Inclusion/Exclusion Criteria may apply.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

CDK2 inhibitor INCB123667. An orally bioavailable inhibitor of cyclin-dependent kinase 2 (CDK2), with potential antineoplastic activity. Upon oral administration, CDK2 inhibitor INCB123667 selectively targets, binds to and inhibits the activity of CDK2. This inhibits retinoblastoma (Rb) phosphorylation and blocks G1/S transition, which leads to cell cycle arrest, the induction of apoptosis, and the inhibition of tumor cell proliferation. CDK2, in complex with cyclin E1 (CCNE1; CCNE-1), phosphorylates Rb, which leads to E2F target gene expression and G1 to S-phase cell cycle progression. CDK2 and CCNE1 are overexpressed in various tumor cell types. NCI Drug Dictionary

Treatments listed in the registry

  • INCB123667 (Drug): Administered orally twice daily (BID).

The study

Treatment groups

Non Randomized · Single Group · masking: None

Cohort 1 (Experimental)

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Cohort 2 (Experimental)

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Cohort 3 (Experimental)

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Goals

What the study measures

Main goals

  • Objective Response by IRC (Up to 2 years)

Other goals

  • Duration of Response (DOR) by IRC
  • Progression-Free Survival (PFS) by IRC
  • Overall Survival (OS)
  • Objective Response by Investigator
  • DOR by investigator
  • PFS by Investigator
  • Treatment Emergent Adverse Events (TEAE'S)
  • TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment

Planned enrollment: 160 (estimated).

Where

Recruiting US sites

  • Usa Health Mitchell Cancer Institute, Mobile, Alabama
  • University of California, Los Angeles Medical Center, Los Angeles, California
  • Scripps Healthscripps Mercy Hospital Prebys Cancer Center, San Diego, California
  • Medstar Georgetown University Hospital, Washington D.C., District of Columbia
  • Florida Cancer Specialists & Research Institute, Fort Myers, Florida
  • Sylvester Comprehensive Cancer Center, Miami, Florida
  • Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida
  • Florida Cancer Specialists & Research Institute, West Palm Beach, Florida
  • Northeast Georgia Medical Center Gainesville, Gainesville, Georgia
  • Parkview Research Center, Fort Wayne, Indiana
  • University of Iowa Hospital and Clinics, Iowa City, Iowa
  • Norton Cancer Institute, Louisville, Kentucky
  • Trials365, Llc, Shreveport, Louisiana
  • Greater Baltimore Medical Center, Baltimore, Maryland
  • Massachusetts General Hospital, Boston, Massachusetts
  • Umass Memorial Medical Center, Inc., Worcester, Massachusetts
  • University of Michigan Health System, Ann Arbor, Michigan
  • Minnesota Oncology-Minneapolis, Minneapolis, Minnesota
  • University of Mississippi Medical Center, Jackson, Mississippi
  • Washington University, St Louis, Missouri
  • St. Vincent Regional Hospital - West End Clinic, Billings, Montana
  • Nebraska Methodist Hospital, Omaha, Nebraska
  • John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey
  • Laura and Isaac Perlmutter Cancer Center, New York, New York
  • State University of New York Upstate Medical Unive, Syracuse, New York
  • Oncology Hematology Care, Inc, Cincinnati, Ohio
  • The Mark H Zangmeister Cancer Center Ohio, Columbus, Ohio
  • The Ohio State University Wexner Medical Center Division of Gynecologic Oncology, Hilliard, Ohio
  • Penn State College of Medicine, Hershey, Pennsylvania
  • Medical University of South Carolina, Charleston, South Carolina
  • Texas Oncology-Austin Center, Austin, Texas
  • Texas Oncology-San Antonio Medical Center Pharmacy, San Antonio, Texas
  • Texas Oncology-Tyler, Tyler, Texas
  • Utah Cancer Specialists, Salt Lake City, Utah
  • Virginia Cancer Specialists, Fairfax, Virginia
  • Carilion Clinic, Roanoke, Virginia
  • West Virginia University, Morgantown, West Virginia
  • Froedtert & the Medical College of Wisconsin, Milwaukee, Wisconsin

36 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 14, 2026. Public record; not medical advice.

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