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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01323933 | First-in-human Study of AB0024 to Evaluate Safety and Tolerability in Adults With Advanced Solid Tumors | PHASE1 | COMPLETED | 32 | — | — | Jun 1, 2010 | Mar 1, 2012 | May 3, 2012 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| AB0024 | EXPERIMENTAL | The starting dose for Part A will be 1 mg/kg. Subsequent doses of 3, 10, and 20 mg/kg are planned. Three to 6 patients will be enrolled using a 3 + 3 design. Doses of AB0024 will be administered on Days 1, 15, 29, and 43 to characterize the safety, tolerability, and PK. The dose expansion phase of the study will begin upon completion of the dose escalation phase. Up to 20 patients will be enrolled into one or two cohorts of Part B. The first expansion cohort will be dosed up to the MTD defined as the highest dose level with an observed incidence of DLT in \<33% of patients enrolled from Part A. |
| Name | Type | Description |
|---|---|---|
| AB0024 | DRUG | Comparison of different dosages of drug |
Inclusion Criteria: * Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to, intolerant of, or for which no standard of therapy is available * Measurable or evaluable disease * ECOG Performance Status of ≤2 * No known active central nervous system (CNS) tumo...