Recruiting
Phase 3

INCB123667 vs. Chemotherapy

Sponsor:

Incyte Corporation

Code:

NCT07214779

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCB123667

Investigator's choice of chemotherapy

Study Details

Brief summary:

The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.

Conditions

Ovarian Cancer

Study ID

NCT07214779

Start date

Dec 9, 2025

Status verified date

Sep, 2026

Completion date

May 14, 2029

Anticipated

Primary completion date

Nov 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histological diagnosis of 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 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.
  • Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.
  • Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.
  • Should have received prior treatment with bevacizumab unless there was a contraindication for its use.
  • Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.
  • Measurable disease per RECIST v1.1.

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, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
  • Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
  • Known active CNS metastases and/or carcinomatous meningitis.
  • Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.
  • Clinically significant gastrointestinal abnormalities.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Enrollment

466 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group A (TGA)

INCB123667 at the protocol-defined dose.

experimental: Treatment Group B (TGB)

Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol.

Interventions

INCB123667

Oral; tablet

Investigator's choice of chemotherapy

The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:

Primary outcome measure

  • Progression-Free Survival (PFS) by BICR [ Time Frame: Up to 2 years ]
  • Overall Survival (OS) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Billings Clinic

Recruiting

Billings, Montana, United States, 59101

Novant Presbyterian Hospital

Recruiting

Charlotte, North Carolina, United States, 28204

Novant Health Oncology Specialists

Recruiting

Winston-Salem, North Carolina, United States, 27103

Oncology Associates of Oregon, P.C.

Recruiting

Eugene, Oregon, United States, 97401

University of Pittsburgh Cancer Institute Cancer Services

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Sanford Cancer Center-Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57104-8805

Erlanger Health, Inc.

Recruiting

Chattanooga, Tennessee, United States, 37403

Texas Oncology-Abilene

Recruiting

Abilene, Texas, United States, 79606

Cedars Cancer Centre - McGill University Health Centre (Muhc) - Glen Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Incyte Corporation

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • INCB123667

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.