{"classes":[{"categories":[{"measurements":[{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG000","spread":"NA","value":"0.940"},{"groupId":"OG001","spread":"74.0","value":"1.85"},{"groupId":"OG002","spread":"15.9","value":"2.92"},{"groupId":"OG003","spread":"60.5","value":"1.37"},{"groupId":"OG004","spread":"18.3","value":"2.04"},{"groupId":"OG005","spread":"52.7","value":"1.84"},{"groupId":"OG006","spread":"16.4","value":"1.22"},{"groupId":"OG007","spread":"12.8","value":"1.36"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG008","spread":"NA","value":"2.53"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG009","spread":"NA","value":"2.30"},{"groupId":"OG010","spread":"22.6","value":"1.35"},{"groupId":"OG011","spread":"34.4","value":"1.33"},{"groupId":"OG012","spread":"40.3","value":"1.46"},{"groupId":"OG013","spread":"31.5","value":"1.36"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"8"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"6"}],"units":"Participants"}],"title":"Conjugated Antibody Cycle 1"},{"categories":[{"measurements":[{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG000","spread":"NA","value":"0.869"},{"groupId":"OG002","spread":"3.98","value":"2.60"},{"groupId":"OG003","spread":"0.345","value":"0.928"},{"groupId":"OG004","spread":"27.8","value":"1.35"},{"groupId":"OG005","spread":"32.8","value":"1.24"},{"groupId":"OG006","spread":"27.4","value":"0.880"},{"groupId":"OG007","spread":"18.9","value":"1.16"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG009","spread":"NA","value":"1.15"},{"groupId":"OG010","spread":"21.0","value":"1.27"},{"groupId":"OG011","spread":"24.4","value":"1.12"},{"groupId":"OG012","spread":"63.2","value":"1.14"},{"groupId":"OG013","spread":"13.1","value":"0.809"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"5"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"3"}],"units":"Participants"}],"title":"Total Antibody Cycle 1"},{"categories":[{"measurements":[{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG000","spread":"NA","value":"0.544"},{"groupId":"OG001","spread":"69.3","value":"2.02"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG002","spread":"NA","value":"1.91"},{"groupId":"OG003","spread":"105","value":"1.01"},{"groupId":"OG004","spread":"18.3","value":"1.57"},{"groupId":"OG005","spread":"21.2","value":"1.18"},{"groupId":"OG006","spread":"19.9","value":"1.02"},{"groupId":"OG007","spread":"17.3","value":"1.16"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG008","spread":"NA","value":"1.82"},{"groupId":"OG009","spread":"6.07","value":"2.11"},{"groupId":"OG010","spread":"35.4","value":"1.44"},{"groupId":"OG011","spread":"43.1","value":"1.43"},{"groupId":"OG012","spread":"10.9","value":"1.47"},{"groupId":"OG013","spread":"30.7","value":"1.23"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"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":"0.449"},{"groupId":"OG001","spread":"86.9","value":"2.05"},{"groupId":"OG002","spread":"48.0","value":"1.43"},{"groupId":"OG003","spread":"88.1","value":"1.02"},{"groupId":"OG004","spread":"20.9","value":"0.994"},{"groupId":"OG005","spread":"64.9","value":"1.25"},{"groupId":"OG006","spread":"15.4","value":"0.830"},{"groupId":"OG007","spread":"26.5","value":"1.04"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG008","spread":"NA","value":"1.16"},{"groupId":"OG009","spread":"16.8","value":"1.58"},{"groupId":"OG010","spread":"28.9","value":"1.08"},{"groupId":"OG011","spread":"36.7","value":"1.13"},{"groupId":"OG012","spread":"19.8","value":"1.07"},{"groupId":"OG013","spread":"15.3","value":"0.890"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"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 1"},{"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":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"8"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"6"}],"units":"Participants"}],"description":"The PK profile included the CL 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\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":"C1D1, from Pre-dose to 4 hr, 96 hr, 168 hr and 336 hr post dose; C2D1, from Pre-dose to 4 hr, 48 hr, 96 hr, 168 hr and 336 hr post dose","title":"Clearance (CL) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody and Unconjugated Warhead SG3199","type":"SECONDARY","unitOfMeasure":"L/day"}