Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Serclutamab Talirine
ABBV-321 · 1 trial · 1 indication
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...
ABBV-321 is an investigational small molecule developed by AbbVie Inc. for advanced solid tumors associated with overexpression of the epidermal growth factor receptor (EGFR). It was studied in a single Phase 1 trial that has completed enrollment of 62 participants across the United States, Australia, and Israel.
ABBV-321 was studied for the treatment of advanced solid tumors associated with overexpression of the epidermal growth factor receptor (EGFR). The Phase 1 trial enrolled adults 18 years and older with these EGFR-overexpressing advanced solid tumors. It is an investigational agent and is not approved for commercial use.
ABBV-321 targets the epidermal growth factor receptor (EGFR). It is a small molecule designed to act against advanced solid tumors associated with overexpression of EGFR, and the Phase 1 study selected participants based on this EGFR overexpression biomarker.
ABBV-321 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the Phase 1 study of the compound in advanced solid tumors associated with EGFR overexpression.
ABBV-321 is in Phase 1 development. It has completed one Phase 1 trial, NCT03234712, which evaluated safety, pharmacokinetics, and anti-tumor activity in 62 participants with advanced solid tumors associated with EGFR overexpression. No active trials are currently listed, and the drug is investigational.
ABBV-321 has been evaluated in one clinical trial, NCT03234712, titled a study evaluating the safety, pharmacokinetics, and anti-tumor activity of ABBV-321 in subjects with advanced solid tumors associated with overexpression of EGFR. That Phase 1 trial is completed, enrolled 62 participants, and was conducted in the United States, Australia, and Israel.