{"groups":[{"description":"Participants received TAK-500, 8 micrograms per kilogram (µg/kg), intravenous (IV) infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.","id":"FG000","title":"Single Agent Dose Escalation: TAK-500 8 µg/kg"},{"description":"Participants received premedication with 8 milligrams per kilogram (mg/kg) (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.","id":"FG001","title":"Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg"},{"description":"Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.","id":"FG002","title":"Single Agent Dose Escalation: TAK-500 16 µg/kg"},{"description":"Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.","id":"FG003","title":"Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.","id":"FG004","title":"Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg"},{"description":"Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"FG005","title":"Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"FG006","title":"Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg"},{"description":"Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"FG007","title":"Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"FG008","title":"Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"FG009","title":"Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg"},{"description":"Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year.","id":"FG010","title":"Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg"},{"description":"Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.","id":"FG011","title":"Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"FG012","title":"Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"FG013","title":"Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg"},{"description":"Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase.","id":"FG014","title":"Dose Expansion: TAK-500"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"2"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"2"},{"groupId":"FG011","numSubjects":"2"},{"groupId":"FG012","numSubjects":"1"},{"groupId":"FG013","numSubjects":"0"},{"groupId":"FG014","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"4"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"2"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"3"},{"groupId":"FG013","numSubjects":"4"},{"groupId":"FG014","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"1"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"2"},{"groupId":"FG011","numSubjects":"2"},{"groupId":"FG012","numSubjects":"2"},{"groupId":"FG013","numSubjects":"0"},{"groupId":"FG014","numSubjects":"0"}],"type":"Reason Not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"6"},{"groupId":"FG009","numSubjects":"4"},{"groupId":"FG010","numSubjects":"5"},{"groupId":"FG011","numSubjects":"5"},{"groupId":"FG012","numSubjects":"7"},{"groupId":"FG013","numSubjects":"5"},{"groupId":"FG014","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"4"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"6"},{"groupId":"FG009","numSubjects":"2"},{"groupId":"FG010","numSubjects":"4"},{"groupId":"FG011","numSubjects":"4"},{"groupId":"FG012","numSubjects":"5"},{"groupId":"FG013","numSubjects":"2"},{"groupId":"FG014","numSubjects":"0"}],"comment":"The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation.","type":"Response-evaluable Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"1"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"1"},{"groupId":"FG011","numSubjects":"1"},{"groupId":"FG012","numSubjects":"1"},{"groupId":"FG013","numSubjects":"1"},{"groupId":"FG014","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"5"},{"groupId":"FG009","numSubjects":"3"},{"groupId":"FG010","numSubjects":"4"},{"groupId":"FG011","numSubjects":"4"},{"groupId":"FG012","numSubjects":"6"},{"groupId":"FG013","numSubjects":"4"},{"groupId":"FG014","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants with the specified pathologically confirmed locally advanced or metastatic solid tumors, whose disease had progressed on or is intolerant to all standard therapy were enrolled in the study. The study was terminated before initiation of Dose Expansion Phase.","recruitmentDetails":"Participants took part in the study at sites in the United States from 14 April 2022 to 06 January 2025."}