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Study of INCB123667 in Subjects With Advanced Solid Tumors

Status
Active
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05238922
Protocol IDs
INCB 123667-101 (primary)
NCI-2022-03370
Study Sponsor
Incyte Corporation

Summary

This is an open-label, dose-escalation and dose-expansion study to determine the safety,
tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when
administered as monotherapy at the RDE(s) in participants with selected advanced or
metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of
INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose
expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy
in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A.

Eligibility

  1. France Only : Adults age of at least 18 and up to 99 years.
  2. Life expectancy greater than 12 weeks.
  3. ECOG performance status score of 0 or 1.
  4. Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.
  5. Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy (core or excisional) as applicable to obtain the specimen. Participants in Part 1B:
  6. Disease Group 1 : Ovarian/Fallopian/Primary Peritoneal Cancer
  7. Disease Group 2 : Endometrial/Uterine Cancer
  8. Disease Group 3: Gastric, GEJ, and esophageal adeno-carcinomas
  9. Disease Group 4 : TNBC
  10. Disease Group 5: Breast cancer (HR+/HER-)
  11. Disease Group 6: Other tumor indications
  12. Measurable lesions by CT or MRI based on RECIST v1.1 criteria that are considered nonamenable to surgery or other curative treatments or procedures.
  13. Willingness to avoid pregnancy or fathering children.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**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.