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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03234712 | A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) | PHASE1 | COMPLETED | 62 | — | — | Oct 10, 2017 | Apr 14, 2021 | May 6, 2021 | 18 | United States, Australia +1 |
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt) for ABBV-321
AUC∞ is the area under the plasma concentration-time curve from Time 0 to infinite time.
Time to Cmax (Tmax) of ABBV-321
Terminal phase elimination rate constant (β)
Maximum observed plasma concentration (Cmax) of ABBV-321
The RPTD will be determined using available safety and pharmacokinetics data upon completion of the Dose Escalation Phase
Terminal elimination half-life (t1/2)
The MTD of ABBV-321 will be determined during the dose escalation phase of the study.
| Arm | Type | Description |
|---|---|---|
| ABBV-321 | EXPERIMENTAL | ABBV-321 will be administered via intravenous infusion at escalating dose levels until the maximum tolerated dose is reached and a recommended Phase 2 dose is determined. |
| Name | Type | Description |
|---|---|---|
| ABBV-321 | DRUG | Intravenous infusion |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Histologically or cytologically confirmed solid tumor of one of the following types associated with overexpression of Epidermal Growth Factor Receptor (EGFR). (For Expansion Phase: Subjects must have EGF...