Study Complete
Sponsor ID
20200040
A Study of AMG 757 in Participants with Neuroendocrine Prostate CancerDeLLpro-300
Study Details
To evaluate the safety and tolerability of Tarlatamab and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
Protocol Summary
Primary Outcome Measures
Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 to 12 months
Number of Participants who Experience One or More Treatment-related Adverse Events
Timeframe: Day 1 to 12 months
Number of Participants who Experience a Clinically Significant Change from Baseline in Vital Signs
Timeframe: Baseline to 12 months
Number of Participants who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Timeframe: Baseline to 12 months
Number of Participants who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Timeframe: Baseline to 12 months
Number of Participants who Experience Dose Limiting Toxicities (DLTs)
Timeframe: Baseline to 12 months
Secondary Outcome Measures
Objective Response (OR)
Timeframe: Baseline to 12 months
Duration of Response (DOR)
Timeframe: Baseline to 12 months
Progression-free Survival (PFS)
Timeframe: Baseline to 12 months
Overall Survival (OS)
Timeframe: Baseline to 12 months
Disease Control Rate (DCR)
Timeframe: Baseline to 12 months
Maximum Serum Concentration (Cmax) of Tarlatamab
Timeframe: Baseline to 12 months
Minimum Serum Concentration (Cmin) of Tarlatamab
Timeframe: Baseline to 12 months
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab
Timeframe: Baseline to 12 months
Accumulation Ratio of Tarlatamab
Timeframe: Baseline to 12 months
Half-life (t1/2) of Tarlatamab
Timeframe: Baseline to 12 months
Study Documents
Plain Language Summary of Results
Available Language(s): French, Dutch, Spanish, English (UK), German (Austria), Dutch (Belgium), French (Belgium), English
Locations
Location
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Status
Recruiting
Location
Peter MacCallum Cancer Centre
Melbourne, VIC, Australia, 3000
Status
Recruiting
Location
Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
Status
Recruiting
Location
Washington University
St. Louis, MO, United States, 63110-1093
Status
Recruiting
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Status
Recruiting
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