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NCT05238922

Study of INCB123667 in Subjects With Advanced Solid Tumors

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Incyte Corporation
~291 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:INCB0123667PalbociclibBevacizumabOlaparibPaclitaxelRibociclib

At a glance

Recruiting sites
0 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)
Measured over Up to Day 28
+4 more outcomes measured

Conditions

Solid Tumors

Explore related trials

Breast CarcinomaEndometrial CarcinomaEsophageal CarcinomaFallopian Tube CarcinomaGastric CarcinomaGEJ CancerMalignant Ovarian NeoplasmMalignant Uterine NeoplasmPrimary Peritoneal CancerSolid Neoplasm

Where it's being run

41 sites across 19 states
Italy5
Japan5
France4
California3
New York3
Pennsylvania3
Switzerland3
United Kingdom3

Study leadership

  • Louis Viviers, MD · STUDY_DIRECTOR · Incyte Corporation

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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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.
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
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.
TGH and TGJ:
Participants with HR+/HER2- breast cancer.
Participants with any other advanced or metastatic solid tumor.
TGI and TGK:
TGL, TGM and TGN:
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.

What this trial measures

  • Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)Up to Day 28

    Toxicities occurring during the first treatment cycle, Part 1a, will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs)Up to 12 months

    TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

  • Number of Participants with Dose Interruptions due to TEAEUp to 12 months

    Participants will receive dose reductions of INCB123667 according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.

  • Number of Participants who Undergo Dose Reductions due to TEAEUp to 12 months

    Participants will receive dose reductions according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.

  • Number of Participants Discontinue study due to TEAEUp to 12 months

    TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.