{"classes":[{"categories":[{"measurements":[{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG000","spread":"NA","value":"823"},{"groupId":"OG001","spread":"26.6","value":"907"},{"groupId":"OG002","spread":"14.7","value":"1000"},{"groupId":"OG003","spread":"98.1","value":"2552"},{"groupId":"OG004","spread":"30.1","value":"2259"},{"groupId":"OG005","spread":"66.0","value":"3708"},{"groupId":"OG006","spread":"30.9","value":"7420"},{"groupId":"OG007","spread":"22.6","value":"8031"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG008","spread":"NA","value":"678"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG009","spread":"NA","value":"873"},{"groupId":"OG010","spread":"19.7","value":"2058"},{"groupId":"OG011","spread":"30.1","value":"2059"},{"groupId":"OG012","spread":"51.5","value":"2725"},{"groupId":"OG013","spread":"34.4","value":"4556"}]}],"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":"1068"},{"groupId":"OG002","spread":"2.40","value":"1331"},{"groupId":"OG003","spread":"10.7","value":"5768"},{"groupId":"OG004","spread":"21.8","value":"3962"},{"groupId":"OG005","spread":"36.2","value":"6594"},{"groupId":"OG006","spread":"40.3","value":"13018"},{"groupId":"OG007","spread":"50.1","value":"9578"},{"comment":"Data not available due to insufficient number of observations to determine geometric coefficient of variation.","groupId":"OG009","spread":"NA","value":"2107"},{"groupId":"OG010","spread":"18.4","value":"2083"},{"groupId":"OG011","spread":"23.6","value":"3552"},{"groupId":"OG012","spread":"77.3","value":"4157"},{"groupId":"OG013","spread":"8.27","value":"7077"}]}],"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"},{"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":"Conjugated 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":"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":"2"},{"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":"1"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"8"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"6"}],"units":"Participants"}],"description":"The PK profile included AUCinf of ADCT-301 in serum total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199. 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 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 4hr, 96hr, 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":"Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of ADCT-301 in Serum Total Antibody, PBD-conjugated Antibody, and Unconjugated Warhead SG3199","type":"SECONDARY","unitOfMeasure":"day*µg/L"}