Home › Trials › NCT05238922

Testing INCB123667 for advanced solid tumors

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors

PHASE1 · Incyte Corporation · NCT05238922

This study is testing a new drug called INCB123667 to see if it can help people with advanced solid tumors, both on its own and when combined with other cancer treatments.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment604 (estimated)
Ages18 Years and up
SexAll
SponsorIncyte Corporation (industry)
Drugs / interventionsradiation
Locations42 sites (Duarte, California and 41 other locations)
Trial IDNCT05238922 on ClinicalTrials.gov

What this trial studies

This open-label, dose-escalation and dose-expansion study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of INCB123667 in patients with advanced or metastatic solid tumors. The study is divided into two parts: Part 1 involves administering INCB123667 as a monotherapy, while Part 2 combines it with other anticancer therapies. Each part includes both a dose escalation and a dose expansion phase to assess the treatment's effects and safety across various tumor types.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with advanced or metastatic solid tumors who have experienced disease progression on prior treatments.

Not a fit: Patients with bone cancers or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific combination and dosing of INCB123667 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Duarte, California and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Solid Tumors, advanced solid tumors, metastatic solid tumors, Gynecological Tumors,, GI Tumors,, Breast Cancer,, Tumor Agnostic, cyclin E1 gene

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.