Study Complete
Sponsor ID
20220073
Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
Study Details
The primary objective of this study is to:
- Evaluate the safety and tolerability of AMG 305 in adult participants
- Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
- Determine the recommended phase 2 dose (RP2D)
Protocol Summary
Primary Outcome Measures
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)
Timeframe: Day 1 to Day 28
Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to a maximum of 2 years
Percentage of Participants who Experience Treatment-Related Adverse Events
Timeframe: Up to a maximum of 2 years
Secondary Outcome Measures
Maximum Serum Concentration (Cmax) of AMG 305
Timeframe: Up to a maximum of 2 years
Minimum Serum Concentration (Cmin) of AMG 305
Timeframe: Up to a maximum of 2 years
Area Under the Concentration-Time Curve (AUC) of AMG 305
Timeframe: Up to a maximum of 2 years
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Timeframe: Up to a maximum of 2 years
ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Timeframe: Up to a maximum of 2 years
Duration of Response (DOR)
Timeframe: Up to a maximum of 2 years
Time to Progression
Timeframe: Up to a maximum of 2 years
Progression-Free Survival (PFS)
Timeframe: Up to a maximum of 2 years
Overall Survival (OS) at 1 Year
Timeframe: 1 year
OS at 2 Years
Timeframe: 2 years
Locations
Location
Peter MacCallum Cancer Centre
Melbourne, VIC, Australia, 3000
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Next Oncology
San Antonio, TX, United States, 78229
Status
Recruiting
Location
New York University Cancer Institute
New York, NY, United States, 10016
Status
Recruiting
Location
Asan Medical Center
Seoul, Republic of Korea, 05505
Status
Recruiting
Location
Seoul National University Hospital
Seoul, Republic of Korea, 03080
Status
Recruiting
Showing {first} - {last} of {total} Results