Spots Global Cancer Trial Database for Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors
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Trial Identification
Brief Title: Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors
Official Title: A Phase 1, Multicenter, Open-label, Dose Exploration and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 994 Monotherapy and Combination of AMG 994 and AMG 404 in Subjects With Advanced Solid Tumors
Study ID: NCT04727554
Conditions
Study Description
Brief Summary: The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumors.
Detailed Description: AMG 994 will be administered by short term intravenous (IV) infusion once weekly in each 28-day cycle and AMG 404 will be administered by short-term IV infusion once every 4 weeks (Q4W) in a 28 day cycle (on day 1 of cycle 2 and beyond). The study will be conducted in 2 parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Henry Ford Hospital, Henry Ford Health Systems, Detroit, Michigan, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Monash Medical Centre, Clayton, Victoria, Australia
Linear Clinical Research Limited, Nedlands, Western Australia, Australia
Universitair Ziekenhuis Gent, Gent, , Belgium
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre Leon Berard, Lyon, , France
Universitatsklinikum Ulm, Ulm, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Warszawa, , Poland
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
University College London Hospital, London, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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