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Brief Title: Study of INCB123667 in Subjects With Advanced Solid Tumors
Official Title: A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors
Study ID: NCT05238922
Brief 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 at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Medical Center, Duarte, California, United States
City of Hope-Lennar Foundation Cancer Center, Irvine, California, United States
Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, 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
Carolina Bio-Oncology Institute, Pllc, Huntersville, North Carolina, United States
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute Cancer Services, Pittsburgh, Pennsylvania, United States
Texas Oncology-Fort Worth South Henderson, Fort Worth, Texas, 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 Del Tumori Di Milano, 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 (Crc), 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
The Cancer Institute Hospital of Jfcr, Koto-ku, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Oncological Institute of Southern Switzerland, Bellinzona, , Switzerland
Inselspital Universitatsklinik Fur Medizinische Onkologie, Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois (Chuv), Lausanne, , Switzerland
Western General Hospital, Edinburgh, , United Kingdom
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
Name: Liz Croft Richards
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR