Study of INCB123667 in Subjects With Advanced Solid Tumors

Last updated: March 24, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Solid Tumors

Treatment

Ribociclib

Palbociclib

INCB0123667

Clinical Study ID

NCT05238922
INCB 123667-101
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 forstandard treatment, or no available treatment to improve the disease outcome.

  • Availability of a baseline archival tumor specimen or willingness to undergo apretreatment 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 orparticipants 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/primaryperitoneal carcinoma.

  • Measurable lesions by CT or MRI based on RECIST v1.1 criteria.

Exclusion

Exclusion Criteria:

  • History of clinically significant or uncontrolled cardiac disease.

  • History or presence of an ECG abnormality that, in the investigator's opinion, isclinically meaningful.

  • Presence of chronic or current active infectious disease requiring systemicantibiotic, antifungal, or antiviral treatment.

  • Untreated brain or central nervous system (CNS) metastases or brain or CNSmetastases that have progressed.

  • Known additional malignancy that is progressing or requires active treatment, orhistory of other malignancy within 2 years of the first dose of study drug.

  • Specific laboratory values.

  • Significant concurrent, uncontrolled medical conditions, including but not limitedto Hepatic and Gastrointestinal.

  • Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/orcomplications 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 isshorter) before the first dose of study drug or any administration of targetedtherapy, antibody, or hypomethylating agent to treat the participant's diseasewithin 5 half-lives or 28 days (whichever is shorter) before the first dose of studydrug.

  • 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 treatedwith an investigational medication within 5 half-lives or 28 days (whichever isshorter) 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 orformulation components.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Total Participants: 604
Treatment Group(s): 7
Primary Treatment: Ribociclib
Phase: 1
Study Start date:
July 05, 2022
Estimated Completion Date:
July 30, 2026

Connect with a study center

  • Institut Bergonie

    Bordeaux, 33076
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69373
    France

    Active - Recruiting

  • Institut Curie

    Paris, 75005
    France

    Site Not Available

  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

    Toulouse, 31059
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif Cedex, 94805
    France

    Active - Recruiting

  • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

    Milan, 20133
    Italy

    Active - Recruiting

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133
    Italy

    Active - Recruiting

  • Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

    Milan, 20133
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Naples, 80131
    Italy

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    Rome, 00168
    Italy

    Active - Recruiting

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Centro Ricerche Cliniche Di Verona

    Verona, 37134
    Italy

    Active - Recruiting

  • Centro Ricerche Cliniche Di Verona (Crc)

    Verona, 37134
    Italy

    Active - Recruiting

  • Aichi Cancer Center Hospital

    Aichi, 464-8681
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Chiba, 277-8577
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Chiba-ken, 277-8577
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of Jfcr

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Erasmus Medical Center

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Panoncology Trials Pan American Center For Oncology Trials, Llc

    Rio Piedras, 00935
    Puerto Rico

    Active - Recruiting

  • Oncological Institute of Southern Switzerland

    Bellinzona, 6500
    Switzerland

    Active - Recruiting

  • Inselspital Universitatsklinik Fur Medizinische Onkologie

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Centre Hospitalier Universitaire Vaudois (Chuv)

    Lausanne, 01011
    Switzerland

    Active - Recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Guys Hospital

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • The Christie Nhs Foundation Trust Uk

    Manchester, M20 4BV
    United Kingdom

    Site Not Available

  • Northern Centre For Cancer Care

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Active - Recruiting

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope-Lennar Foundation Cancer Center

    Irvine, California 92618
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Completed

  • Mount Sinai Medical Center Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • New York Presbyterian/Weill Cornell

    New York, New York 10065
    United States

    Active - Recruiting

  • Weill Cornell Breast Center

    New York, New York 10065
    United States

    Site Not Available

  • Ny Cancer and Blood Specialists

    Shirley, New York 11967
    United States

    Site Not Available

  • Carolina Bio-Oncology Institute, Pllc

    Huntersville, North Carolina 28078
    United States

    Completed

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • University of Pittsburgh Cancer Institute Cancer Services

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Oncology

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Oncology-Fort Worth South Henderson

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Virginia Cancer Institute

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

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