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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
77
Short-term intravenous (IV) infusion
Short-term IV infusion
City of Hope National Medical Center
Duarte, California, United States
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Time frame: Day 1 to Day 21
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.
Time frame: Up to 2 years
Number of Participants Who Experience a Treatment-related AE
Time frame: Up to 2 years
Maximum Observed Serum Concentration (Cmax) of AMG 355
Time frame: Up to 85 days
Minimum Observed Serum Concentration (Cmin) of AMG 355
Time frame: Up to 85 days
Area Under the Concentration-time Curve (AUC) of AMG 355
Time frame: Up to 85 days
Confirmed Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: Up to 2 years
Clinical Benefit per RECIST v1.1
Time frame: Up to 2 years
Duration of Response per RECIST v1.1
Time frame: Up to 2 years
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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
...and 15 more locations
Time to Progression by RECIST v1.1
Time frame: Up to 2 years
Progression-free Survival (PFS) by RECIST v1.1
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Change From Baseline in C-C motif chemokine receptor 8 (CCR8+) Expression Between Pre and On Treatment Tumor Samples
Time frame: Up to 2 years