Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of advanced solid tumors cancer. It is designed for patients with tumors that overexpress the epidermal growth factor receptor (EGFR). The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
ABBV-321 targets the epidermal growth factor receptor (EGFR), which is overexpressed in certain advanced solid tumors. By targeting EGFR, the drug aims to interfere with tumor growth and progression. This mechanism is being evaluated in a Phase 1 clinical trial to assess its safety, pharmacokinetics, and anti-tumor activity.
ABBV-321 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical research to evaluate the drug's potential in treating advanced solid tumors associated with EGFR overexpression.
ABBV-321 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains under investigation for its safety and efficacy in patients with advanced solid tumors.
ABBV-321 has one completed Phase 1 clinical trial, identified as NCT03234712. This study evaluated the safety, pharmacokinetics, and anti-tumor activity of ABBV-321 in subjects with advanced solid tumors associated with EGFR overexpression. The trial enrolled 62 participants and was conducted in the United States, Australia, and Israel.
ABBV-321 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial data. It is a small molecule being developed by AbbVie for advanced solid tumors with EGFR overexpression, and it is distinct from other EGFR-targeting agents in the company's pipeline.