Study of INCB123667 in Subjects With Advanced Solid Tumors
Esophogeal Cancer
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Stomach/ Gastric Cancer
18 Years and older, Male and Female
INCB 123667-101 (primary)
NCI-2022-03370
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 and in combination with anticancer therapies in participants
with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In
Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be
administered in combination with anticancer therapies of interest. Each part will
comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion
portion (Parts 1b and 2b, respectively).
Eligibility
- Adults aged 18 years or older at the time of the signing of the ICF.
- Life expectancy greater than 12 weeks.
- ECOG performance status score of 0 or 1.
- Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.
- Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy. For Part 1: Participants in Part 1A (dose escalation): Histologically or cytologically confirmed
advanced or metastatic solid tumors. Participants in Part 1B (dose expansion):
- Disease Group 1: Ovarian/Fallopian/Primary Peritoneal Cancer
- Disease Group 2: Endometrial/Uterine Cancer
- Disease Group 3: Gastric, GEJ, and esophageal carcinomas
- Disease Group 4: TNBC
- Disease Group 5: HR+/HER2- breast cancer
- Disease Group 6: Other tumor indications excluding bone cancers For Part 2: Participants in Part 2A (dose escalation): Histologically or cytologically confirmed
advanced or metastatic solid tumors.
- TGA, TGC, TGE, TGF, and TGG: Participants with HR+/HER2- breast cancer or participants with a different tumor.
- TGB and TGD: Participants with HR+/HER2- breast cancer. Participants in Part 2b (dose expansion):
- TGH and TGJ:
- Participants with HR+/HER2- breast cancer.
- Participants with any other advanced or metastatic solid tumor.
- TGI and TGK: • Participants with HR+/HER2- breast cancer.
- TGL, TGM and TGN: • Participants with advanced or metastatic epithelial ovarian/fallopian/primary peritoneal carcinoma.
- Measurable lesions by CT or MRI based on RECIST v1.1 criteria.
Treatment Sites in Georgia
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