{"classes":[{"categories":[{"measurements":[{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG000","spread":"NA","value":"1.00"},{"groupId":"OG001","spread":"0.175","value":"1.00"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG002","spread":"NA","value":"1.00"},{"groupId":"OG003","spread":"7.42","value":"1.09"},{"groupId":"OG004","spread":"0.621","value":"1.01"},{"groupId":"OG005","spread":"2.41","value":"1.02"},{"groupId":"OG006","spread":"4.67","value":"1.04"},{"groupId":"OG007","spread":"2.39","value":"1.03"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG008","spread":"NA","value":"1.00"},{"groupId":"OG009","spread":"0.123","value":"1.00"},{"groupId":"OG010","spread":"1.05","value":"1.01"},{"groupId":"OG011","spread":"0.570","value":"1.00"},{"groupId":"OG012","spread":"0.258","value":"1.00"},{"groupId":"OG013","spread":"1.28","value":"1.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"6"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"3"}],"units":"Participants"}],"title":"Conjugated Antibody Cycle 2"},{"categories":[{"measurements":[{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG000","spread":"NA","value":"1.00"},{"groupId":"OG001","spread":"0.248","value":"1.00"},{"groupId":"OG002","spread":"0.124","value":"1.00"},{"groupId":"OG003","spread":"3.59","value":"1.03"},{"groupId":"OG004","spread":"0.819","value":"1.01"},{"groupId":"OG005","spread":"3.12","value":"1.02"},{"groupId":"OG006","spread":"6.87","value":"1.05"},{"groupId":"OG007","spread":"4.03","value":"1.05"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG008","spread":"NA","value":"1.10"},{"groupId":"OG009","spread":"0.257","value":"1.00"},{"groupId":"OG010","spread":"3.73","value":"1.03"},{"groupId":"OG011","spread":"0.305","value":"1.00"},{"groupId":"OG012","spread":"0.757","value":"1.01"},{"groupId":"OG013","spread":"3.01","value":"1.04"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"3"}],"units":"Participants"}],"title":"Total Antibody Cycle 2"},{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"0"}],"units":"Participants"}],"title":"Unconjugated SG3199 Cycle 2"}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"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":"2"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"6"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"3"}],"units":"Participants"}],"description":"The PK profile included AI of ADCT-301 in serum total antibody and PBD-conjugated antibody. For participants treated with ADCT-301 in combination with pembrolizumab, the collection of PK data was stopped upon consultation with the Sponsor if ADCT-301 administration was discontinued and pembrolizumab continues.\n\nAI is the ratio of accumulation of a drug under steady state conditions (i.e., after repeated administration) as compared to a single dose.\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.\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":"C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose","title":"Accumulation Index (AI) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199","type":"SECONDARY","unitOfMeasure":"ratio"}