Study Complete
Sponsor ID
20220028
A Study of AMG 355 Alone and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors
Study Details
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.
Protocol Summary
Primary Outcome Measures
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Timeframe: Day 1 to Day 21
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Up to 2 years
Number of Participants Who Experience a Treatment-related AE
Timeframe: Up to 2 years
Secondary Outcome Measures
Maximum Observed Serum Concentration (Cmax) of AMG 355
Timeframe: Up to 85 days
Minimum Observed Serum Concentration (Cmin) of AMG 355
Timeframe: Up to 85 days
Area Under the Concentration-time Curve (AUC) of AMG 355
Timeframe: Up to 85 days
Confirmed Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Timeframe: Up to 2 years
Clinical Benefit per RECIST v1.1
Timeframe: Up to 2 years
Duration of Response per RECIST v1.1
Timeframe: Up to 2 years
Time to Progression by RECIST v1.1
Timeframe: Up to 2 years
Progression-free Survival (PFS) by RECIST v1.1
Timeframe: Up to 2 years
Overall Survival
Timeframe: Up to 2 years
Change From Baseline in C-C motif chemokine receptor 8 (CCR8+) Expression Between Pre and On Treatment Tumor Samples
Timeframe: Up to 2 years
Locations
Location
Alliance for Multispecialty Research - Kansas City
Merriam, KS, United States, 66204
Status
Completed
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
South Texas Accelerated Research Therapeutics
San Antonio, TX, United States, 78229
Status
Recruiting
Location
The Queen Elizabeth Hospital
Woodville South, SA, Australia, 5011
Status
Recruiting
Location
Asan Medical Center
Seoul, Republic of Korea, 138-736
Status
Recruiting
Location
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Status
Recruiting
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