{"classes":[{"categories":[{"measurements":[{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG002","spread":"NA","value":"0.104"},{"groupId":"OG003","spread":"23.4","value":"0.0352"},{"groupId":"OG005","spread":"26.4","value":"0.0575"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG006","spread":"NA","value":"0.117"},{"groupId":"OG007","spread":"32.1","value":"0.0329"},{"groupId":"OG008","spread":"27.1","value":"0.0390"},{"groupId":"OG009","spread":"24.3","value":"0.0536"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"3"}],"units":"Participants"}],"title":"Cycle 1 Day 1"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"24.6","value":"0.150"},{"groupId":"OG002","spread":"36.9","value":"0.0675"},{"groupId":"OG003","spread":"43.3","value":"0.0319"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG004","spread":"NA","value":"0.0660"},{"groupId":"OG005","spread":"14.2","value":"0.0624"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"}],"units":"Participants"}],"title":"Cycle 1 Day 15"},{"categories":[{"measurements":[{"groupId":"OG002","spread":"31.1","value":"0.0678"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG006","spread":"NA","value":"0.0640"},{"groupId":"OG007","spread":"36.9","value":"0.0456"},{"groupId":"OG008","spread":"26.8","value":"0.0404"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG009","spread":"NA","value":"0.0716"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"1"}],"units":"Participants"}],"title":"Cycle 2 Day 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"3"}],"units":"Participants"}],"description":"Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. V(ss) = (dose/AUC)\\*MRT, where MRT is mean residence time. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG000","title":"Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg"},{"description":"Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG001","title":"Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg"},{"description":"Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG002","title":"Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg"},{"description":"Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG003","title":"Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg"},{"description":"Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.","id":"OG004","title":"Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg"},{"description":"Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.","id":"OG005","title":"Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg"},{"description":"Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG006","title":"Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg"},{"description":"Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG007","title":"Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg"},{"description":"Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG008","title":"Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg"},{"description":"Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG009","title":"Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK Analysis Set; Overall number analyzed: participants with data available for analysis.Number analyzed: participants with data available during specified time-point.Given low exposure at 0.01mg/kg dose,there was insufficient data to characterize terminal phase PK required for calculating this parameter.Consequently,this parameter has been marked as \"Not Calculated\" and therefore not reported for Part 1,Schedule A,0.01mg/kg dose group,in accordance with non-compartmental PK analysis standards.","reportingStatus":"POSTED","timeFrame":"Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)","title":"Part 1: Vss: Volume of Distribution at Steady State for Modakafusp Alfa","type":"SECONDARY","unitOfMeasure":"liters/kg"}