NM32-2668 in Adult Patients With Selected Advanced Solid Tumors

Assessment of the maximum observed serum concentration (Cmax)

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of the the minimum observed serum concentration (Cmin)

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Time from dosing at which maximum observed serum concentration is apparent (Tmax)

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of the terminal phase (apparent elimination) rate constant (λz)

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of the elimination half-life (t½)

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity])

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of the area under serum concentration-time curve over dosing interval (AUCtau)

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of clearance (CL) of NM32-2668 in serum

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of the volume of distribution (Vd) of NM32-2668 in serum

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Frequency of specific anti-drug antibodies (ADAs) to NM32-2668

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Concentration of specific ADAs to NM32-2668

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Incidence of specific ADAs by category to NM32-2668

Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation

Best Overall Response (BOR) according to RECIST 1.1

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment

Overall Response Rate (ORR) according to RECIST 1.1

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment

Disease Control Rate (DCR) according to RECIST 1.1

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment

Progression-free Survival (PFS) according to RECIST 1.1

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion (on average, 1 year after last treatment)

Time to Response (TTR) according to RECIST 1.1

Time frame: From date of randomization until the date of first documented treatment response according to RECIST 1.1

Duration of Response (DOR) according to RECIST 1.1

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion (on average, 1 year after last treatment)

Overall Survival (OS)

Time frame: From date of randomization until the date of death from any cause, assessed through study completion (on average, 1 year after last treatment)