RecruitingPhase 1NCT05238922

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

Sponsor

Incyte Corporation

Enrollment

604 participants

Start Date

Jul 5, 2022

Study Type

INTERVENTIONAL

Conditions

Solid Tumors

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial tests a new investigational drug called INCB123667 in patients with advanced solid tumors — including ovarian, endometrial, breast, gastric, and other cancers — to determine the safest dose and whether it shows early signs of effectiveness. **You may be eligible if...** - You are 18 or older with an advanced or metastatic solid tumor that has progressed on standard treatments - You are in generally good health (ECOG performance status 0 or 1) with a life expectancy over 12 weeks - You are willing to provide a tumor biopsy sample - Specific cancer types are prioritized in the expansion phases (e.g., ovarian, endometrial, breast cancer) **You may NOT be eligible if...** - You have uncontrolled heart disease, active infections, or untreated brain metastases - You have had prior treatment with a CDK2 inhibitor - You have had recent surgery, radiation, or another investigational drug within the required washout period - You have known HIV, active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINCB0123667

25 mg tablets

DRUGPalbociclib

Palbociclib will be administered at protocol defined dose.

DRUGBevacizumab

Bevacizumab will be administered at protocol defined dose.

DRUGOlaparib

Olaparib will be administered at protocol defined dose.

DRUGPaclitaxel

Paclitaxel will be administered at protocol defined dose.

DRUGRibociclib

Ribociclib will be administered at protocol defined dose.

DRUGFulvestrant

Fulvestrant will be administered at protocol defined dose.

Locations(42)

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

Memorial Sloan Kettering Cancer Center

New York, New York, United States

New York Presbyterian/Weill Cornell

New York, New York, United States

Ny Cancer and Blood Specialists

Shirley, New York, United States

Carolina Bio-Oncology Institute, Pllc

Huntersville, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute Cancer Services

Pittsburgh, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology-Fort Worth South Henderson

Fort Worth, Texas, United States

Virginia Cancer Institute

Fairfax, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

Institut Bergonie

Bordeaux, France

Centre Leon Berard

Lyon, France

Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, Italy

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, Italy

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, Italy

Irccs Istituto Clinico Humanitas

Rozzano, Italy

Centro Ricerche Cliniche Di Verona

Verona, Italy

Aichi Cancer Center Hospital

Aichi, Japan

National Cancer Center Hospital East

Chiba-ken, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Japan

National Cancer Center Hospital

Tokyo, Japan

The Cancer Institute Hospital of Jfcr

Tokyo, Japan

Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Panoncology Trials Pan American Center For Oncology Trials, Llc

Rio Piedras, Puerto Rico

Oncological Institute of Southern Switzerland

Bellinzona, Switzerland

Inselspital Universitatsklinik Fur Medizinische Onkologie

Bern, Switzerland

Centre Hospitalier Universitaire Vaudois (Chuv)

Lausanne, Switzerland

Guys Hospital

London, United Kingdom

Imperial College Healthcare Nhs Trust - Hammersmith Hospital

London, United Kingdom

Northern Centre For Cancer Care

Newcastle upon Tyne, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05238922

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