Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cmax: Maximum Observed Plasma Concentration for Dazostinag [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Dazostinag [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Dazostinag [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity for Dazostinag [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: t1/2z: Terminal Disposition Phase Half-life for Dazostinag [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: CL: Total Clearance After Intravenous Administration for Dazostinag [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Vss: Volume of Distribution at Steady State After Intravenous Administration for Dazostinag [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: CLR: Renal Clearance for Dazostinag [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Percentage of Dose Excreted in Urine During 24 Hours After Dosing [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: CLR/CL%: Renal Clearance as Percentage of Total Clearance for Dazostinag [Time Frame: Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Cycle 1 Days 1, 8 and 15: pre-infusion and at multiple time points (up to 24 hours) post-infusion and at Day 1 for further cycles up to 54 months (Cycle length=21 days)]
Dose Escalation Phase: Percentage of Dose Excreted in Feces During 24 Hours After Dosing [Time Frame: Dose Escalation Phase: Cycle 1 Day 1: from start of infusion and at multiple time points (up to 24 hours) post-infusion (Cycle length=21 days)]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Overall Response Rate (ORR) [Time Frame: Up to approximately 54 months]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Disease Control Rate (DCR) [Time Frame: Up to approximately 54 months]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Duration of Response (DOR) [Time Frame: Up to approximately 54 months]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Time to Response (TTR) [Time Frame: Up to approximately 54 months]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Fold Change from Baseline in Upregulation of Dazostinag-induced Stimulator of Interferon Genes (STING) [Time Frame: Baseline up to Month 54]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Fold Change from Baseline in T-cell Infiltration Upon Dazostinag Treatment [Time Frame: Baseline up to Month 54]
Dose Escalation, Japan Safety Lead-in, and Expansion Phases: Fold Change from Baseline of Genomic, Transcriptomic and Protein Expressions in Tumor Tissues [Time Frame: Baseline up to Month 54]
Expansion Phase Only: Progression-Free Survival (PFS) [Time Frame: Up to approximately 24 months]
Expansion Phase Only: Overall Survival (OS) [Time Frame: Up to approximately 24 months]
Expansion Phase Only: OS Rate at 12 Months [Time Frame: Up to 24 months]
Expansion Phase Only: OS Rate at 6 Months [Time Frame: Up to 24 months]
