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Clinical Trials in the UK / NCT05238922
Active, not recruiting Phase 1

Study of INCB123667 in Subjects With Advanced Solid Tumors

NCT05238922 · tracked via the Priya Life Science UK tracker
Sponsor
Incyte Corporation
Phase
Phase 1
Started
2022-07-05
Last updated
2026-07-21

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

INCB0123667PalbociclibBevacizumabOlaparibPaclitaxelRibociclibFulvestrant

INCB0123667: 25 mg tablets

Palbociclib: Palbociclib will be administered at protocol defined dose.

Bevacizumab: Bevacizumab will be administered at protocol defined dose.

Olaparib: Olaparib will be administered at protocol defined dose.

Paclitaxel: Paclitaxel will be administered at protocol defined dose.

Ribociclib: Ribociclib will be administered at protocol defined dose.

Fulvestrant: Fulvestrant will be administered at protocol defined dose.

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
City of Hope Medical Center Duarte California
City of Hope-Lennar Foundation Cancer Center Irvine California
Valkyrie Clinical Trials Los Angeles California
Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
Yale Cancer Center New Haven Connecticut
Mount Sinai Medical Center Comprehensive Cancer Center Miami Beach Florida
Emory University Atlanta Georgia
Memorial Sloan Kettering Cancer Center New York New York
New York Presbyterian/Weill Cornell New York New York
Ny Cancer and Blood Specialists Shirley New York
Carolina Bio-Oncology Institute, Pllc Huntersville North Carolina
University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania
University of Pittsburgh Cancer Institute Cancer Services Pittsburgh Pennsylvania
Allegheny Health Network Pittsburgh Pennsylvania
Tennessee Oncology Nashville Tennessee
Texas Oncology-Fort Worth South Henderson Fort Worth Texas
Virginia Cancer Institute Fairfax Virginia
University of Wisconsin Madison Wisconsin
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

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05238922 on ClinicalTrials.gov ↗ ← All trials in the UK