{"classes":[{"categories":[{"measurements":[{"comment":"Vss could not be assessed at these dose levels as insufficient serum concentration values were above the lower limit of detection.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"0.4 - 2 mg BI-1206 (Cohort 1, starting dose and first intra patient escalation dose)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"60.6","upperLimit":"208","value":"84.2"}]}],"title":"10 - 50 mg BI-1206 (Cohort 1, intra patient dose escalation)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"50.5","upperLimit":"182","value":"81.0"}]}],"title":"100 mg BI-1206 (Cohort 2) Dose 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"124","upperLimit":"143","value":"126"}]}],"title":"100 mg BI-1206 (Cohort 2) Dose 4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"Volume of distribution after administration of BI-1206","dispersionType":"Full Range","groups":[{"description":"BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy).\n\nBI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.","id":"OG000","title":"Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase"},{"description":"Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts).\n\nCombination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.","id":"OG001","title":"Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase"},{"description":"Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.\n\nBI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.","id":"OG002","title":"Part B: Arm1: BI-1206 Single Agent Expansion Phase"},{"description":"Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients.\n\nCombination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.","id":"OG003","title":"Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase"}],"paramType":"MEDIAN","populationDescription":"Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort.","reportingStatus":"POSTED","timeFrame":"Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)","title":"Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206","type":"SECONDARY","unitOfMeasure":"mL/kg"}