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2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"193","value":"0.0670"},{"groupId":"OG001","spread":"33.1","value":"0.0280"},{"groupId":"OG002","spread":"122","value":"0.0440"},{"groupId":"OG003","spread":"115","value":"0.0760"},{"groupId":"OG004","spread":"91.9","value":"0.112"},{"groupId":"OG005","spread":"79.5","value":"0.0550"},{"groupId":"OG006","spread":"1.12","value":"0.0310"},{"groupId":"OG007","spread":"173","value":"0.0860"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG008","spread":"NA","value":"0.0330"},{"groupId":"OG009","spread":"92.5","value":"0.0740"},{"groupId":"OG010","spread":"112","value":"0.0690"},{"groupId":"OG011","spread":"106","value":"0.102"},{"groupId":"OG012","spread":"130","value":"0.101"},{"groupId":"OG013","spread":"9.93","value":"0.171"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"7"},{"groupId":"OG011","value":"7"},{"groupId":"OG012","value":"3"},{"groupId":"OG013","value":"3"}],"units":"Participants"}],"title":"Total Antibody Cycle 2"},{"categories":[{"measurements":[{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG003","spread":"NA","value":"0.168"},{"groupId":"OG004","spread":"0","value":"0.174"},{"groupId":"OG005","spread":"4298","value":"0.280"},{"groupId":"OG006","spread":"3.17","value":"0.170"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG010","spread":"NA","value":"1.12"},{"groupId":"OG011","spread":"2.32","value":"0.169"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG012","spread":"NA","value":"0.0320"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG013","spread":"NA","value":"0.161"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"2"},{"groupId":"OG012","value":"1"},{"groupId":"OG013","value":"1"}],"units":"Participants"}],"title":"Unconjugated SG3199 Cycle 2"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"10"},{"groupId":"OG011","value":"9"},{"groupId":"OG012","value":"4"},{"groupId":"OG013","value":"6"}],"units":"Participants"}],"description":"The pharmacokinetic (PK) profile included determination of Tmax in serum Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. For participants treated with camidanlumab tesirine in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration is discontinued and pembrolizumab continues.\n\nUpon consultation with the Sponsor, no further PK samples were collected, ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.","id":"OG000","title":"ADCT-301 Monotherapy 20 µg/kg"},{"description":"Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.","id":"OG001","title":"ADCT-301 Monotherapy 30 µg/kg"},{"description":"Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.","id":"OG002","title":"ADCT-301 Monotherapy 45 µg/kg"},{"description":"Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.","id":"OG003","title":"ADCT-301 Monotherapy 60 µg/kg"},{"description":"Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.","id":"OG004","title":"ADCT-301 Monotherapy 80 µg/kg"},{"description":"Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.","id":"OG005","title":"ADCT-301 Monotherapy 100 µg/kg"},{"description":"Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.","id":"OG006","title":"ADCT-301 Monotherapy 125 µg/kg"},{"description":"Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.","id":"OG007","title":"ADCT-301 Monotherapy 150 µg/kg"},{"description":"Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).","id":"OG008","title":"ADCT-301 Combination Therapy 20 µg/kg + Pemb"},{"description":"Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).","id":"OG009","title":"ADCT-301 Combination Therapy 30 µg/kg + Pemb"},{"description":"Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).","id":"OG010","title":"ADCT-301 Combination Therapy 45 µg/kg + Pemb"},{"description":"Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).","id":"OG011","title":"ADCT-301 Combination Therapy 60 µg/kg + Pemb"},{"description":"Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).","id":"OG012","title":"ADCT-301 Combination Therapy 80 µg/kg + Pemb"},{"description":"Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).","id":"OG013","title":"ADCT-301 Combination Therapy 100 µg/kg + Pemb"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK Analysis Set: The PK analysis set consisted of all participants who received study drug and had at least 1 pre-C1D1 and 1 post-dose valid assessment. Includes participants with available data at each timepoint.\n\nThe overall number of participants analyzed represents the number of participants with available PK data at any timepoint.\n\nIncludes participants with available data at each timepoint.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 1 (C1D1), from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; Cycle 2 Day 1 (C2D1), from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose","title":"Time to Maximum Concentration (Tmax) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199","type":"SECONDARY","unitOfMeasure":"days"}