{"groups":[{"description":"This is dose level 1 of the dose escalation phase (Phase 1) of the study.\n\nTinostamustine at dose of 60mg/m2 administered i.v. over 30min on D1 and D15 of each 4-week cycle.\n\nThe decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.","id":"FG000","title":"Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min). Cohort 1"},{"description":"This is dose level 2 of the dose escalation phase (Phase 1) of the study.\n\nTinostamustine at dose of 80mg/m2 administered i.v. over 30min on D1 and D15 of each 4-week cycle.\n\nThe decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.","id":"FG001","title":"Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min). Cohort 2"},{"description":"This is dose level 3 of the dose escalation phase (Phase 1) of the study.\n\nTinostamustine at dose of 100mg/m2 administered i.v. over 30min on D1 and D15 of each 4-week cycle.\n\nIn the 30-minute infusion study drug dosing had to be delayed in subsequent cycles due to thrombocytopenia, which was associated with an extremely high Cmax of Tinostamustine. To ensure that subjects continue the study treatment safely, the Sponsor decided to stop the investigation of the 30-minute infusion time and open cohorts with the 60-minute infusion in 3 subjects with relapse/refractory solid tumors.","id":"FG002","title":"Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min). Cohort 3."},{"description":"This is dose level 4 of the dose escalation phase (Phase 1) of the study.\n\nTinostamustine at dose of 60mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.\n\nThe decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.","id":"FG003","title":"Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min). Cohort 4"},{"description":"This is dose level 5 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.\n\nThe decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.","id":"FG004","title":"Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min). Cohort 5"},{"description":"This is dose level 6 of the dose escalation phase (Phase 1) of the study.\n\nDLT of electrocardiogram QTc prolongation occurred 1 patient. Considering the DLT observed in this cohort and the rapid occurrence of treatment-induced thrombocytopenia (not meeting the DLT definitions), the SRC concluded as follows:\n\n* The dose of 100 mg/m2 was determined the MAD.\n* The dose level of 80 mg/m2 given i.v. over 60 minutes was determined to be the MTD\n* The dose level of 80 mg/m2 given i.v. over 60 minutes on Day 1 and Day 15 of each 4-week treatment cycle was determined to be the RP2D.","id":"FG005","title":"Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min). Cohort 6"},{"description":"Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.","id":"FG006","title":"Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort."},{"description":"Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.","id":"FG007","title":"Tinostamustine (EDO-S101) - Phase 2 STS Cohort."},{"description":"Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.","id":"FG008","title":"Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort."},{"description":"Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.","id":"FG009","title":"Tinostamustine (EDO-S101) - Phase 2 OC Cohort."},{"description":"Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.","id":"FG010","title":"Tinostamustine (EDO-S101) - Phase 2 EC Cohort."},{"description":"Tinostamustine at dose of 60mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.","id":"FG011","title":"Tinostamustine (EDO-S101) - Substudy 1"},{"description":"Tinostamustine at dose of 80mg/m2 administered i.v. over 80min on D1 and D15 of each 4-week cycle.","id":"FG012","title":"Tinostamustine (EDO-S101) - Substudy 2"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"2"},{"groupId":"FG011","numSubjects":"3"},{"groupId":"FG012","numSubjects":"3"}],"type":"Do not have a post-dose tumour assessment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"8"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"10"},{"groupId":"FG008","numSubjects":"4"},{"groupId":"FG009","numSubjects":"12"},{"groupId":"FG010","numSubjects":"6"},{"groupId":"FG011","numSubjects":"6"},{"groupId":"FG012","numSubjects":"7"}],"comment":"Patients Treated","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"8"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"8"},{"groupId":"FG008","numSubjects":"4"},{"groupId":"FG009","numSubjects":"12"},{"groupId":"FG010","numSubjects":"4"},{"groupId":"FG011","numSubjects":"3"},{"groupId":"FG012","numSubjects":"4"}],"comment":"Phase 1: Patients are reported as completed if they have completed cycle 1. Phase 2: Patients who have at least 1 post-baseline tumour response assessment is reported as completed.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"2"},{"groupId":"FG011","numSubjects":"3"},{"groupId":"FG012","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Adults with histologically confirmed diagnosis of advanced or metastatic solid tumors, disease should have progressed during or following at least 1 previous line of therapy and no other standard therapy with proven clinical benefit is available or recommended based on the investigator's individual risk-benefit assessment for the patient.","recruitmentDetails":"Subjects were recruited by physicians at the study sites between Nov-2017 and Aug-2022."}