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

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

Status
Active
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 - 99 Years, Male and Female
Study Type
Treatment
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

  1. Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  2. Have platinum-resistant disease:
  3. Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen.
  4. 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.
  5. 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.
  6. 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.
  7. Must have received bevacizumab unless there was a contraindication for its use.
  8. If the tumor tests positive for FRa, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.

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.