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RECRUITINGPHASE1

Study of INCB123667 in Subjects With 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

NCT05238922•Incyte Corporation

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+17 more 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.
+6 more criteria

Locations (46)

City of Hope Medical Center

Duarte, California, United States

City of Hope-Lennar Foundation Cancer Center

Irvine, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Mount Sinai Medical Center Comprehensive Cancer Center

Miami Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

July 5, 2022

Primary Completion Date

July 27, 2027

Completion Date

August 31, 2027

Last Updated

February 10, 2026

Enrollment

604

ESTIMATED participants

Conditions

Solid Tumors

Interventions

INCB0123667

DRUG

Palbociclib

DRUG

Bevacizumab

DRUG

Olaparib

DRUG

Paclitaxel

DRUG

Ribociclib

DRUG

Fulvestrant

DRUG

Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423 eumedinfo@incyte.com

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Advanced Solid Tumors CancerMSI-H Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of INCB123667 in Subjects With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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