Primary Outcome Measures
Incidence and nature of adverse events [Time Frame: up to 30 months] [Designated as safety issue: ]
Secondary Outcome Measures
Incidence of antidrug antibody (ADA) formation to the fully human monoclonal antibody (AGS62P) and antibody-conjugate (ASP1235 [AGS62P1]) [Time Frame: up to 54 months] [Designated as safety issue: ]
Complete response (CR) [Time Frame: up to 54 months] [Designated as safety issue: ]
Composite complete remission (CRc) rate [Time Frame: up to 54 months] [Designated as safety issue: ]
Best response rate [Time Frame: up to 54 months] [Designated as safety issue: ]
Duration of remission [Time Frame: up to 54 months] [Designated as safety issue: ]
Duration of response [Time Frame: up to 54 months] [Designated as safety issue: ]
Morphologic leukemia free state (MLFS) rate [Time Frame: up to 30 months] [Designated as safety issue: ]
Concentration at the end of infusion (CEOI) of total antibody (TAb) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Concentration at the end of infusion (CEOI) of antibody drug conjugate (ADC) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Concentration at the end of infusion (CEOI) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Maximum observed concentration (Cmax) of total antibody (TAb) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Maximum observed concentration (Cmax) of antibody drug conjugate (ADC) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Maximum observed concentration (Cmax) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Time to maximum concentration (Tmax) of total antibody (TAb) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Time to maximum concentration (Tmax) of antibody drug conjugate (ADC) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Time to maximum concentration (Tmax) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Partial area under the serum concentration-time curve (AUC) of total antibody (TAb) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Partial area under the serum concentration-time curve (AUC) of antibody drug conjugate (ADC) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Partial area under the serum concentration-time curve (AUC) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Terminal or apparent terminal half-life (t1/2) of total antibody (TAb) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Terminal or apparent terminal half-life (t1/2) of antibody drug conjugate (ADC) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Terminal or apparent terminal half-life (t1/2) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Systemic clearance (CL) of total antibody (TAb) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Systemic clearance (CL) of antibody drug conjugate (ADC) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Systemic clearance (CL) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Volume of distribution at steady state (Vss) of total antibody (TAb) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Volume of distribution at steady state (Vss) of antibody drug conjugate (ADC) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Volume of distribution at steady state (Vss) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Concentration at the end of infusion (CEOI) of total antibody (TAb) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Concentration at the end of infusion (CEOI) of antibody drug conjugate (ADC) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Concentration at the end of infusion (CEOI) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Maximum observed concentration (Cmax) of total antibody (TAb) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Maximum observed concentration (Cmax) of antibody drug conjugate (ADC) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Maximum observed concentration (Cmax) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Time to maximum concentration (Tmax) of total antibody (TAb) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Time to maximum concentration (Tmax) of antibody drug conjugate (ADC) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Time to maximum concentration (Tmax) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Partial area under the serum concentration-time curve (AUC) of total antibody (TAb) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Partial area under the serum concentration-time curve (AUC) of antibody drug conjugate (ADC) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Partial area under the serum concentration-time curve (AUC) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Terminal or apparent terminal half-life (t1/2) of total antibody (TAb) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Terminal or apparent terminal half-life (t1/2) of antibody drug conjugate (ADC) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Terminal or apparent terminal half-life (t1/2) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Systemic clearance (CL) of total antibody (TAb) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Systemic clearance (CL) of antibody drug conjugate (ADC) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Systemic clearance (CL) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Volume of distribution at steady state (Vss) of total antibody (TAb) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Volume of distribution at steady state (Vss) of antibody drug conjugate (ADC) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]
Volume of distribution at steady state (Vss) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part [Time Frame: up to an average of 30 months] [Designated as safety issue: ]