{"classes":[{"categories":[{"measurements":[{"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":"2"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"1"},{"groupId":"OG013","value":"0"},{"groupId":"OG014","value":"0"},{"groupId":"OG015","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"4"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"7"},{"groupId":"OG013","value":"3"},{"groupId":"OG014","value":"5"},{"groupId":"OG015","value":"4"}],"units":"Participants"}],"description":"* Grade (gr) 5 not related to disease progression or other causes\n* Gr ≥3 non-hematologic toxicity; exceptions: gr 3 nausea, vomiting or diarrhea controlled in 72 hours; gr 3 fatigue \\<5 days; gr ≥3 correctable electrolyte abnormalities \\<72 hours and no clinical complications; gr ≥3 amylase or lipase without clinical pancreatitis\n* Hy's law cases\n* Gr 3 AST or ALT or gr 3 bilirubinemia \\>5 days\n* Hematologic DLTs: gr 4 neutropenia or thrombocytopenia \\>7 days, febrile neutropenia, gr ≥3 thrombocytopenia with bleeding\n* Gr 4 immune-related AEs\n* Gr 3 or 4 non-infectious pneumonitis\n* Gr 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to gr ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to gr 1 or baseline in 14 days\n* Gr 2 pneumonitis not downgrading to gr 1 in 3 days\n* Gr 3 colitis\n* Part B and Part B1: Recurrent grade 2 pneumonitis","groups":[{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG000","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG001","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG002","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG003","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG004","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG005","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG006","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG007","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.","id":"OG008","title":"Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.","id":"OG009","title":"Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG010","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG011","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG012","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 6 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG013","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG014","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG015","title":"Part B1 (Nanrilkefusp Alfa Divided Dosing, Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Through Cycle 1 (21 days)","title":"Number of Participants With Dose-limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}