NCT05238922 · Incyte Corporation
Study of INCB123667 in Subjects With Advanced Solid Tumors
What this study is about
This is an where both patients and doctors know the treatment given, gradually increasing doses and dose-expansion study to determine the safety, tolerability, PK, how the drug affects the body, and preliminary effectiveness of INCB123667 when administered as treatment given alone and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Duarte, California
- Irvine, California
- Los Angeles, California
- Lone Tree, Colorado
- New Haven, Connecticut
- Miami Beach, Florida
- Atlanta, Georgia
- New York, New York
- Shirley, New York
- Huntersville, North Carolina
- Cleveland, Ohio
- Philadelphia, Pennsylvania
And 5 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations