Status:
RECRUITING
Study of INCB123667 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Incyte Corporation
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of clinically significant or uncontrolled cardiac disease.
- History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.
- Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.
- Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study drug.
- Specific laboratory values.
- Significant concurrent, uncontrolled medical conditions, including but not limited to Hepatic and Gastrointestinal.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study drug.
- Prior treatment with any CDK2 inhibitor.
- Any change in endocrine therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug or any administration of targeted therapy, antibody, or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
- Any major surgery within 28 days before the first dose of study drug.
- Any prior radiation therapy within 28 days before the first dose of study drug.
- Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
- Active HBV or HCV infection that requires treatment.
- Known history of HIV.
- Known hypersensitivity or severe reaction to any component of study treatment or formulation components.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT05238922
Start Date
July 5 2022
End Date
August 31 2027
Last Update
December 31 2025
Active Locations (46)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
City of Hope-Lennar Foundation Cancer Center
Irvine, California, United States, 92618
3
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
4
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States, 80124