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Study of INCB123667 in Subjects With Advanced Solid Tumors

NCT05238922 · Incyte Corporation
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Official title
A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors
About this study
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 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.
Study design
Enrollment target: 604 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-07-05
Estimated completion: 2027-08-31
Last updated: 2026-04-14
Interventions
Drug: INCB0123667Drug: PalbociclibDrug: BevacizumabDrug: OlaparibDrug: PaclitaxelDrug: RibociclibDrug: Fulvestrant
Primary outcomes
  • Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) (Up to Day 28)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Up to 12 months)
  • Number of Participants with Dose Interruptions due to TEAE (Up to 12 months)
Sponsor
Incyte Corporation · industry
Contacts & investigators
ContactIncyte Corporation Call Center (US) · contact · medinfo@incyte.com · 1.855.463.3463
ContactIncyte Corporation Call Center (ex-US) · contact · eumedinfo@incyte.com · +800 00027423
InvestigatorLiz Croft, MD · study_director, Incyte Corporation
All locations (42)
City of Hope Medical CenterRecruiting
Duarte, California, United States
City of Hope-Lennar Foundation Cancer CenterRecruiting
Irvine, California, United States
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
Rocky Mountain Cancer Centers-Sky RidgeRecruiting
Lone Tree, Colorado, United States
Yale Cancer CenterCompleted
New Haven, Connecticut, United States
Mount Sinai Medical Center Comprehensive Cancer CenterRecruiting
Miami Beach, Florida, United States
Emory UniversityCompleted
Atlanta, Georgia, United States
Memorial Sloan Kettering Cancer CenterCompleted
New York, New York, United States
New York Presbyterian/Weill CornellCompleted
New York, New York, United States
Ny Cancer and Blood SpecialistsNot Yet Recruiting
Shirley, New York, United States
Carolina Bio-Oncology Institute, PllcCompleted
Huntersville, North Carolina, United States
Cleveland ClinicWithdrawn
Cleveland, Ohio, United States
University of Pennsylvania Abramson Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute Cancer ServicesCompleted
Pittsburgh, Pennsylvania, United States
Allegheny Health NetworkNot Yet Recruiting
Pittsburgh, Pennsylvania, United States
Tennessee OncologyNot Yet Recruiting
Nashville, Tennessee, United States
Texas Oncology-Fort Worth South HendersonCompleted
Fort Worth, Texas, United States
Virginia Cancer InstituteRecruiting
Fairfax, Virginia, United States
University of WisconsinNot Yet Recruiting
Madison, Wisconsin, United States
Institut BergonieRecruiting
Bordeaux, France
Centre Leon BerardRecruiting
Lyon, France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-OncopoleRecruiting
Toulouse, France
Institut Gustave RoussyRecruiting
Villejuif, France
Fondazione Irccs Istituto Nazionale Dei TumoriRecruiting
Milan, Italy
Istituto Nazionale Tumori Irccs Fondazione PascaleCompleted
Naples, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro CuoreRecruiting
Rome, Italy
Irccs Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Centro Ricerche Cliniche Di VeronaRecruiting
Verona, Italy
Aichi Cancer Center HospitalRecruiting
Aichi, Japan
National Cancer Center Hospital EastRecruiting
Chiba-ken, Japan
Saitama Medical University International Medical CenterRecruiting
Hidaka-shi, Japan
National Cancer Center HospitalRecruiting
Tokyo, Japan
The Cancer Institute Hospital of JfcrRecruiting
Tokyo, Japan
Netherlands Cancer Institute Antoni Van Leeuwenhoek ZiekenhuisRecruiting
Amsterdam, Netherlands
Erasmus Medical CenterRecruiting
Rotterdam, Netherlands
Panoncology Trials Pan American Center For Oncology Trials, LlcRecruiting
Rio Piedras, Puerto Rico
Oncological Institute of Southern SwitzerlandRecruiting
Bellinzona, Switzerland
Inselspital Universitatsklinik Fur Medizinische OnkologieRecruiting
Bern, Switzerland
Centre Hospitalier Universitaire Vaudois (Chuv)Recruiting
Lausanne, Switzerland
Guys HospitalRecruiting
London, United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith HospitalRecruiting
London, United Kingdom
Northern Centre For Cancer CareRecruiting
Newcastle upon Tyne, United Kingdom
Study of INCB123667 in Subjects With Advanced Solid Tumors · TrialPath