Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02561234 | A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors | PHASE1 | COMPLETED | 98 | — | — | Oct 1, 2015 | May 1, 2019 | Nov 5, 2021 | 11 | United States |
the dose level at which no more than 1/6 patients experiences dose-limiting toxicity
| Arm | Type | Description |
|---|---|---|
| AEB1102 Dose Escalation Cohort 1 | EXPERIMENTAL | 3 patients dosed at 0.01 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 2 | EXPERIMENTAL | 4 patients dosed at 0.02 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 3 | EXPERIMENTAL | 4 patients dosed at 0.04 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 4 | EXPERIMENTAL | 4 patients dosed at 0.08 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 5 | EXPERIMENTAL | 3 patients dosed at 0.12 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 6 | EXPERIMENTAL | 4 patients dosed at 0.18 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 7 | EXPERIMENTAL | 5 patients dosed at 0.27 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 8 | EXPERIMENTAL | 7 patients dosed at 0.40 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 9 | EXPERIMENTAL | 7 patients dosed at 0.33 mg/kg until MTD determined MTD determined at 0.33 mg/kg |
| AEB1102 Expansion | EXPERIMENTAL | Uveal: 11 patients dosed at 0.33 mg/kg Cutaneous Melanoma: 11 dosed at 0.33 mg/kg SCLC: 13 patients dosed at 0.33 mg/kg |
| Name | Type | Description |
|---|---|---|
| Co-ArgI-PEG | DRUG | Administered IV |
Inclusion Criteria: For patients participating in any part of the trial: * has an advanced solid tumor previously treated with, or inability to tolerate, standard therapy for the disease, or for which a standard therapy does not exist, and as such is considered a candidate for Phase 1 treatment * ...