Time activity curves (TACs) of [177Lu]Lu-NeoB in organs and tumor lesions
Time frame · Cycles 1, 3 and 5: Day 1 (1-4 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) (1 cycle = 4 weeks)
Time activity curves (TACs) for the various organs and lesions will be produced as percentage of injected dose in selected organs and lesions.
Absorbed radiation doses of [177Lu]Lu-NeoB in organs and tumor lesions
Time frame · Cycles 1, 3 and 5: Day 1 (1-4 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) (1 cycle = 4 weeks)
The absorbed dose in target organs will be summarized with descriptive statistics.
Concentration of [177Lu]Lu-NeoB in blood over time
Time frame · Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Blood concentration of \[177Lu\]Lu-NeoB will be summarized with descriptive statistics.
Observed maximum blood concentration (Cmax) of [177Lu]Lu-NeoB
Time frame · Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Cmax will be listed and summarized using descriptive statistics.
Time of maximum observed drug concentration occurrence (Tmax) of [177Lu]Lu-NeoB
Time frame · Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Tmax will be listed and summarized using descriptive statistics.
Area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of [177Lu]Lu-NeoB
Time frame · Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. AUClast will be listed and summarized using descriptive statistics.
Total systemic clearance for intravenous administration (CL) of [177Lu]Lu-NeoB
Time frame · Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. CL will be listed and summarized using descriptive statistics.
Volume of distribution during the terminal phase following intravenous elimination (Vz) of [177Lu]Lu-NeoB
Time frame · Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Vz will be listed and summarized using descriptive statistics.
Terminal elimination half-life (T^1/2) of [177Lu]Lu-NeoB
Time frame · Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. T\^1/2 will be listed and summarized using descriptive statistics.
Objective Response Rate (ORR)
Time frame · From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 60 months
Objective Response Rate (ORR) is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as per local review and according to RECIST 1.1.