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

Status
Active
Cancer Type
Ovarian Cancer
Trial Phase
Phase II
Eligibility
, Male and Female
Study Type
NCT ID
NCT07023627
Protocol IDs
INCB123667-203 (primary)
GOG-3129/INCB123667-203 ( Other Identifier ) (OTHE
2025-521513-14-00 ( Registry Identifier ) (REGISTR
Study Sponsor
Incyte Corporation

Summary

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.

Eligibility

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.

Treatment Sites in Georgia

Northeast Georgia Medical Center - Gainesville


NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.