{"groups":[{"description":"Participants received TAK-186, Dose A as an intravenous (IV) infusion, every week (QW) until disease progression (PD), completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.","id":"FG000","title":"Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone"},{"description":"Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.","id":"FG001","title":"Dose Escalation Phase: TAK-186 - Dose B + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.","id":"FG002","title":"Dose Escalation Phase: TAK-186 - Dose B → Dose C + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.","id":"FG003","title":"Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose E is higher than Dose C and B.","id":"FG004","title":"Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.","id":"FG005","title":"Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.","id":"FG006","title":"Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B and C.","id":"FG007","title":"Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.","id":"FG008","title":"Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone"},{"description":"Participants with non-small cell lung cancer (NSCLC) received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.","id":"FG009","title":"Cohort Expansion Phase: NSCLC"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"1"},{"groupId":"FG009","numSubjects":"7"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"8"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"1"},{"groupId":"FG009","numSubjects":"12"}],"type":"Sponsor Request"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"10"},{"groupId":"FG005","numSubjects":"5"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"3"},{"groupId":"FG008","numSubjects":"5"},{"groupId":"FG009","numSubjects":"12"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"17"},{"groupId":"FG005","numSubjects":"13"},{"groupId":"FG006","numSubjects":"5"},{"groupId":"FG007","numSubjects":"4"},{"groupId":"FG008","numSubjects":"8"},{"groupId":"FG009","numSubjects":"31"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"16"},{"groupId":"FG005","numSubjects":"13"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"3"},{"groupId":"FG008","numSubjects":"8"},{"groupId":"FG009","numSubjects":"29"}],"comment":"Participants who received at least 1 dose of TAK-186 and had a baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample for assessment were included in the population.","type":"Immunogenicity Population"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"14"},{"groupId":"FG005","numSubjects":"11"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"7"},{"groupId":"FG009","numSubjects":"0"}],"comment":"Participants who received at least 3 target doses of TAK-186 in a dose cohort, or at least 2 target doses of TAK-186, or experienced a DLT within the DLT-evaluation period were included in DLT evaluable population.","type":"Dose Limiting Toxicity (DLT) Evaluable Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"1"},{"groupId":"FG009","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"16"},{"groupId":"FG005","numSubjects":"13"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"3"},{"groupId":"FG008","numSubjects":"7"},{"groupId":"FG009","numSubjects":"31"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"The study comprised two phases: a Dose-Escalation Phase and a Cohort Expansion Phase. The dose-escalation phase was followed by a cohort-expansion phase. The study was terminated early due to the sponsor's strategic decision to discontinue the TAK-186 development program based on the limited anti-cancer activity of TAK-186 as a single agent.","recruitmentDetails":"A total of 95 participants took part in the study from 08 March 2021 to 17 June 2025."}