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A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Sponsor: Amgen
Summary
The primary objectives of this study are to: * Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors * Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.
Official title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
77
Start Date
2024-03-07
Completion Date
2026-08-03
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
AMG 355
Short-term intravenous (IV) infusion
Pembrolizumab
Short-term IV infusion
Locations (25)
City of Hope National Medical Center
Duarte, California, United States
Alliance for Multispecialty Research - Kansas City
Merriam, Kansas, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
St Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Institut Bergonie
Bordeaux, France
Gustave Roussy
Villejuif, France
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, Poland
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, Switzerland
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan