This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated in an expansion cohort at the RP2D for safety and anti-tumor activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
The antibody AV-203 is a humanized immunoglobulin G1/kappa (IgG1/κ) monoclonal antibody that targets the receptor tyrosine kinase (RTK) ERBB3 and inhibits ERBB3 activities. AV-203 will be administered as a 60 to 75-minute IV infusion once every 2 weeks until disease progression or unacceptable toxicity.
AVEO Clinical Site
Scottsdale, Arizona, United States
AVEO Clinical Site
Atlanta, Georgia, United States
AVEO Clinical Site
San Antonio, Texas, United States
Incidence of AEs, SAEs and Dose-limiting Toxicities (DLTs)
Time frame: Ongoing throughout study. DLTs evaluated for first cycle of therapy. 1 cycle = 28 days
Maximum Plasma Concentration (Cmax) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Time to Cmax (Tmax) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Area Under Plasma Concentration (AUC) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Terminal phase half-life (t1/2) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Clearance (Cl) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Volume of Distribution (Vd) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Objective Response Rate (ORR)
Time frame: Within 28 days of first dose and every 8 weeks while on study
Disease Control Rate (DCR)
Time frame: Within 28 days of first dose and every 8 weeks while on study
Duration of Response (DOR)
Time frame: Within 28 days of first dose and every 8 weeks while on study
Time to Progression (TTP)
Time frame: Within 28 days of first dose and every 8 weeks while on study
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