Primary Outcome Measures
Confirmed objective response rate (cORR) per RECIST 1.1 per blinded independent central review (BICR) in pooled Cohorts A+B [Time Frame: Up to 8 months] [Designated as safety issue: ]
Secondary Outcome Measures
ORR at 12 weeks of treatment per RECIST 1.1 according to BICR assessment [Time Frame: Up to 12 weeks] [Designated as safety issue: ]
Duration of response (DOR) per RECIST 1.1 according to BICR assessment [Time Frame: Up to approximately 4 years] [Designated as safety issue: ]
Progression-free survival (PFS) per RECIST 1.1 according to BICR assessment for pooled Cohorts A+B [Time Frame: Up to approximately 4 years] [Designated as safety issue: ]
Overall survival (OS) in pooled Cohorts A+B [Time Frame: Up to approximately 4 years] [Designated as safety issue: ]
Incidence of adverse events (AEs) [Time Frame: Through 30 days following last dose; up to approximately 9 months overall per subject] [Designated as safety issue: ]
Incidence of dose modifications [Time Frame: Through 30 days following last dose; up to approximately 9 months overall per subject] [Designated as safety issue: ]
Incidence of laboratory abnormalities [Time Frame: Through 30 days following last dose; up to approximately 9 months overall per subject] [Designated as safety issue: ]