{"classes":[{"categories":[{"measurements":[{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG002","spread":"NA","value":"0.0268"},{"groupId":"OG003","spread":"83.7","value":"0.00358"},{"groupId":"OG005","spread":"32.9","value":"0.0147"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG006","spread":"NA","value":"0.0283"},{"groupId":"OG007","spread":"45.3","value":"0.00258"},{"groupId":"OG008","spread":"102.9","value":"0.00380"},{"groupId":"OG009","spread":"108.4","value":"0.00628"}]}],"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":"21.3","value":"0.0415"},{"groupId":"OG002","spread":"37.9","value":"0.0167"},{"groupId":"OG003","spread":"66.5","value":"0.00261"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG004","spread":"NA","value":"0.00820"},{"groupId":"OG005","spread":"22.0","value":"0.0149"}]}],"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":"49.2","value":"0.0143"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG006","spread":"NA","value":"0.00540"},{"groupId":"OG007","spread":"52.1","value":"0.00226"},{"groupId":"OG008","spread":"55.3","value":"0.00306"},{"comment":"Geometric coefficient of variation was not estimable for a single participant.","groupId":"OG009","spread":"NA","value":"0.00700"}]}],"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":"Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL = dose/AUC. 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: CL: Clearance for Modakafusp Alfa","type":"SECONDARY","unitOfMeasure":"liters per hour per kilogram (L/h/kg)"}