Study Complete
Sponsor ID
20200040

A Study of AMG 757 in Participants with Neuroendocrine Prostate CancerDeLLpro-300

Sponsor ID
20200040
Clinicaltrials.gov ID
NCT04702737
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

To evaluate the safety and tolerability of Tarlatamab and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Additional Study Details

Phase
Phase 1
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
41
Additional Study Details

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
Status
Contact Us
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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