Primary Outcome Measures
Incidence of Dose Limiting Toxicities (DLTs) [Time Frame: Through the end of 1 or 2 cycles, total duration up to 6 weeks (for Part 1A each cycle is 2 weeks; for Part 1B each cycle is 2 or 3 weeks)] [Designated as safety issue: ]
Objective Response Rate (ORR) for Part 2B [Time Frame: Continuous throughout study assessment (up to approximately 1 year)] [Designated as safety issue: ]
Secondary Outcome Measures
Overall safety profile [Time Frame: Continuous throughout study assessment (up to approximately 1 year)] [Designated as safety issue: ]
Progression free survival (PFS) [Time Frame: Continuous throughout study assessment (up to approximately 1 year)] [Designated as safety issue: ]
Time to progression (TTP) [Time Frame: Continuous throughout study assessment (up to approximately 1 year)] [Designated as safety issue: ]
Objective Response Rate (ORR) Part 2A [Time Frame: Continuous throughout study assessment (up to approximately 1 year)] [Designated as safety issue: ]
Duration of response Part 2B [Time Frame: Continuous throughout study assessment (up to approximately 1 year)] [Designated as safety issue: ]
Disease Control Rate Part 2B [Time Frame: Continuous throughout study assessment (up to approximately 1 year)] [Designated as safety issue: ]
Immunogenicity evaluation [Time Frame: Up to approximately 1 year] [Designated as safety issue: ]
Cmax for SAR439459 and for cemiplimab [Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22] [Designated as safety issue: ]
AUC for SAR439459 [Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22] [Designated as safety issue: ]
AUC0-tau for SAR439459 and for cemiplimab [Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22] [Designated as safety issue: ]
t1/2z for SAR439459 [Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22] [Designated as safety issue: ]
CL for SAR439459 [Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22] [Designated as safety issue: ]
Vss for SAR439459 [Time Frame: Cycle 1, Day 1 to Day 15 or to Day 22] [Designated as safety issue: ]