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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-escalation AV-203 Monotherapy | Experimental | dose-escalation of monotherapy AV-203 (an ERBB3 inhibitory antibody) by IV every two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV-203 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs, SAEs and Dose-limiting Toxicities (DLTs) | Ongoing throughout study. DLTs evaluated for first cycle of therapy. 1 cycle = 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of AV-203 | pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose | |
| Time to Cmax (Tmax) of AV-203 | pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AVEO Clinical Site | Scottsdale | Arizona | 85258 | United States | ||
| AVEO Clinical Site |
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| ID | Term |
|---|---|
| C000602877 | AV-203 |
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|
| Area Under Plasma Concentration (AUC) of AV-203 |
| pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose |
| Terminal phase half-life (t1/2) of AV-203 | pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose |
| Clearance (Cl) of AV-203 | pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose |
| Volume of Distribution (Vd) of AV-203 | pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose |
| Objective Response Rate (ORR) | Within 28 days of first dose and every 8 weeks while on study |
| Disease Control Rate (DCR) | Within 28 days of first dose and every 8 weeks while on study |
| Duration of Response (DOR) | Within 28 days of first dose and every 8 weeks while on study |
| Time to Progression (TTP) | Within 28 days of first dose and every 8 weeks while on study |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| AVEO Clinical Site | San Antonio | Texas | 78229 | United States |