Home › Trials › NCT07023627

INCB123667 for platinum-resistant ovarian cancer with Cyclin E1 overexpression

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

Phase 2 Interventional Incyte Corporation · NCT07023627

This study tests whether INCB123667 can help people with platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer whose tumors overexpress Cyclin E1.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years to 99 Years
SexFemale
SponsorIncyte Corporation Industry-sponsored
Drugs / interventionsbevacizumab, mirvetuximab
Locations82 sites (Mobile, Alabama and 81 other locations)
Trial IDNCT07023627 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional trial giving INCB123667 to participants with platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that shows Cyclin E1 overexpression. Eligible participants must have had 1–4 prior lines of systemic therapy, meet the study definition of platinum resistance, and provide a pretreatment biopsy or an archival tumor sample no older than five years. Participants are expected to have received bevacizumab unless it was contraindicated, and treatment will occur at multiple U.S. cancer centers under Incyte sponsorship with ENGOT and GOG collaboration. The protocol focuses on safety and signs of anti-tumor activity in this molecularly selected population.

Who should consider this trial

Good fit: Ideal candidates are adults with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum-resistant, have 1–4 prior lines of systemic therapy, tumors that overexpress Cyclin E1, and are willing to provide a pretreatment biopsy (or archival tissue ≤5 years).

Not a fit: Patients whose tumors do not overexpress Cyclin E1, who are platinum-sensitive, have had more than four prior systemic lines, or who cannot provide suitable tissue are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a targeted treatment option for patients with platinum-resistant ovarian cancers driven by Cyclin E1 overexpression.

How similar studies have performed: Targeting Cyclin E1 is a relatively novel strategy with limited published clinical data to date and mixed early‑phase results for related approaches.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Mobile, Alabama and 81 other locations

+32 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 2026-06-13 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.