Sponsor: Incyte Corporation (industry)
Phase: 2
Start date: June 17, 2025
Planned enrollment: 160
INCB123667 is an investigational, oral CDK2 inhibitor being studied for advanced solid tumors, particularly ovarian cancer with cyclin E1 overexpression. Human results are available from an early-phase study; they do not yet establish how the drug compares with standard treatment. A randomized phase 3 trial in platinum-resistant ovarian cancer began enrolling patients in December 2025. (clinicaltrials.gov)
CDK2 partners with cyclin E1, encoded by CCNE1, to help drive cell-cycle progression. INCB123667 selectively inhibits CDK2. Tumors with increased cyclin E1 activity are a focus of development because they may be more dependent on this pathway. (aacrjournals.org)
In a phase 1 study, 19 of 90 patients (21.1%) with heavily pretreated, platinum-resistant or platinum-refractory ovarian cancer had an objective response to INCB123667 alone: four complete and 15 partial responses. Among 30 patients receiving two selected dosing regimens in the expansion cohort, 10 (33.3%) responded. These are preliminary, non-comparative results; 18 of the 19 responders had cyclin E1 overexpression. (asco.org)
In that ovarian-cancer group, the most commonly reported treatment-emergent adverse events were nausea (56.7%), anemia (37.8%), and vomiting (36.7%). 38 of 90 patients (42.2%) had an event of grade 3 or higher, and three (3.3%) discontinued treatment because of an adverse event. “Treatment-emergent” does not necessarily mean caused by the drug. (asco.org)
Last updated: Sep 2026
Goal: Evaluate the antitumor activity and safety of INCB123667 in platinum-resistant ovarian cancer with cyclin E1 overexpression.
Patients: Participants with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer and platinum-resistant disease after 1–4 prior lines of systemic therapy. Prior bevacizumab is required unless contraindicated; patients with FRα-positive tumors must generally have received mirvetuximab soravtansine. Primary platinum-refractory disease is excluded.
Design: Nonrandomized, single-arm study with three cohorts defined by tumor cyclin E1 expression. There is no comparator arm.
Treatments: All cohorts receive INCB123667 at a protocol-defined dose. This investigational oral CDK2 inhibitor targets the cyclin E1–CDK2 pathway involved in cell-cycle progression. In a prior phase 1 ovarian cancer cohort, 19 of 90 patients (21.1%) had an objective response; these preliminary, noncomparative results do not establish benefit relative to standard treatment.
Outcomes: The primary endpoint is confirmed objective response by independent review committee using RECIST v1.1. Secondary endpoints include duration of response, progression-free survival, overall survival, investigator-assessed response and disease-control measures, treatment-emergent adverse events, and adverse events leading to dose interruption, reduction, or discontinuation.
Burden on patient: Estimated moderate burden. Participants need tumor tissue testing and may require a pretreatment biopsy if suitable archival tissue is unavailable. Oral treatment avoids infusion visits, but response imaging, safety assessments, and study follow-up require visits; the supplied information does not specify their frequency or additional pharmacokinetic blood draws.
Last updated: Sep 2026
Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.
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.
Kortrijk, 08500, Belgium
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Brussels, B-1200, Belgium
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Brussels, 01070, Belgium
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Leuven, 03000, Belgium
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Sapporo, 060-8648, Japan
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Akashi-shi, 673-8558, Japan
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Kurume, 830-0011, Japan
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Hidaka-shi, 350-1298, Japan
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Matsuyama, 791-0280, Japan
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Madrid, 28027, Spain
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