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INCB123667 versus doctor‑chosen chemotherapy for platinum‑resistant ovarian cancer with cyclin E1 overexpression.

A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Phase 3 Interventional Incyte Corporation · NCT07214779

This trial will see if INCB123667 works better than a doctor‑chosen chemotherapy in people with platinum‑resistant ovarian, fallopian tube, or primary peritoneal cancer whose tumors overexpress cyclin E1.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment466 (estimated)
Ages18 Years and up
SexFemale
SponsorIncyte Corporation Industry-sponsored
Drugs / interventionsbevacizumab, mirvetuximab, chemotherapy
Locations162 sites (Anchorage, Alaska and 161 other locations)
Trial IDNCT07214779 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares the investigational drug INCB123667 to investigator's choice single‑agent chemotherapy in participants with high‑grade serous ovarian, fallopian tube, or primary peritoneal cancer that is platinum‑resistant and shows cyclin E1 overexpression. Eligible participants must have received 1–4 prior lines of systemic therapy after diagnosis, have available archival tumor tissue (or agree to a pretreatment biopsy), and generally should have received prior bevacizumab and mirvetuxi unless contraindicated. Participants are assigned to receive INCB123667 or a physician‑selected chemotherapy regimen and will be followed for efficacy and safety outcomes. The study is sponsored by Incyte Corporation with academic collaborators and is conducted at multiple U.S. cancer centers.

Who should consider this trial

Good fit: Ideal candidates are adults with high‑grade serous ovarian, fallopian tube, or primary peritoneal cancer that is platinum‑resistant, whose tumors overexpress cyclin E1, who have had 1–4 prior systemic therapy lines, and who can provide tumor tissue or undergo biopsy.

Not a fit: Patients without cyclin E1 overexpression, those with platinum‑sensitive disease, more than four prior systemic lines, or who cannot provide tumor tissue or tolerate the study treatments are unlikely to benefit.

Why it matters

Potential benefit: If successful, INCB123667 could provide a new effective treatment option for patients with platinum‑resistant, cyclin E1‑overexpressing ovarian cancer.

How similar studies have performed: Targeting cyclin E1 is a relatively novel approach with limited clinical data to date, so while early‑phase signals may exist, large randomized proof of benefit remains unestablished.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Anchorage, Alaska and 161 other locations

+112 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian CancerINCB123667
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.