A Study of Tarlatamab in Combination with AB248 in Participants with Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
Study Details
The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.
The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.
Protocol Summary
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 2.5 years
Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)
Timeframe: Up to 35 days
Maximum Serum Concentration (Cmax) of Tarlatamab
Timeframe: Up to approximately 21 weeks
Minimum Serum Concentration (Cmin) of Tarlatamab
Timeframe: Up to approximately 21 weeks
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Timeframe: Up to approximately 21 weeks
Half-life (t1/2) of Tarlatamab
Timeframe: Up to approximately 21 weeks
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timeframe: Up to 2.5 years
Duration of Response (DOR) per RECIST 1.1
Timeframe: Up to 2.5 years
Time to Response (TTR) per RECIST 1.1
Timeframe: Up to 2.5 years
Disease Control (DC) per RECIST 1.1
Timeframe: Up to 2.5 years
Progression-free Survival (PFS) per RECIST 1.1
Timeframe: Up to 2.5 years
Time to Progression (TTP) per RECIST 1.1
Timeframe: Up to 2.5 years
Time to Subsequent Therapy
Timeframe: Up to 2.5 years
Overall Survival (OS)
Timeframe: Up to 2.5 years
Number of Participants with Anti-AB248 Antibody Formation
Timeframe: Up to 2.5 years