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

Launched by INCYTE CORPORATION · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called INCB123667 for women with a type of ovarian cancer that has stopped responding to standard platinum-based chemotherapy. Specifically, it focuses on patients whose cancer shows too much of a protein called Cyclin E1. The goal is to see if this drug is safe to use and if it can help control the cancer in these patients.

Women who may be eligible for this study are those diagnosed with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that no longer responds to platinum therapy after at least one or up to four previous treatments. Participants need to have tumor samples available or be willing to have a biopsy before starting. They should have already tried certain other treatments, like bevacizumab, and if their tumor tests positive for a protein called FRα, they should have received a related therapy unless it wasn’t possible for medical reasons. The study is not open yet but will include women between the ages of about 36 and 74. It’s important to note that women with other types of ovarian cancer or certain serious health problems won’t be eligible. Participants will be closely monitored throughout the trial to assess how well the drug works and to watch for any side effects.

Gender

FEMALE

Eligibility 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.
• • 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 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.