Study Complete
Sponsor ID
20200439

AMG 757 and AMG 404 in Subjects with Small Cell Lung Cancer (SCLC)

Sponsor ID
20200439
Clinicaltrials.gov ID
NCT04885998
EUCTIS ID
N/A
EudraCT ID
2020-005957-26

Study Details

The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.

Additional Study Details

Phase
Phase 1
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
23
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with a Dose Limiting Toxicity (DLT)

Timeframe: 28 days

Number of Participants with a Treatment-emergent Adverse Event (TEAE)

Timeframe: 24 months

Number of Participants with a Treatment-related Adverse Event

Timeframe: 24 months

Number of Participants with a Clinically Significant Change from Baseline in Vital Signs

Timeframe: Baseline to Month 24

Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements

Timeframe: Baseline to Month 24

Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests

Timeframe: Baseline to Month 24

Secondary Outcome Measures

Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Timeframe: 24 months

Duration of Response (DOR)

Timeframe: 24 months

Disease Control Rate (DCR)

Timeframe: 24 months

Progression-free Survival (PFS)

Timeframe: 24 months

Overall Survival (OS)

Timeframe: 24 months

Maximum Observed Concentration (Cmax) of Tarlatamab in Combination with AMG 404

Timeframe: 24 months

Minimum Observed Concentration (Cmin) of Tarlatamab in Combination with AMG 404

Timeframe: 24 months

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab in Combination with AMG 404

Timeframe: 24 months

Locations

Location
Status
Contact Us
Location
Tennessee Oncology, PLLC
Nashville, TN, United States, 37203
Status
Recruiting
Location
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Status
Recruiting
Location
University Hospitals Cleveland Medical Center
Cleveland, OH, United States, 44106
Status
Recruiting
Location
Medizinische Universitaet Innsbruck
Innsbruck, Austria, 6020
Status
Recruiting
Location
Wake Forest Baptist Comprehensive Cancer Research Center
Winston Salem, NC, United States, 27157
Status
Recruiting
Location
Taipei Veterans General Hospital
Taipei, Taipei, Taiwan, 11217
Status
Recruiting
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