A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Solid Tumors
- Interventions
- Biological: AV-203
- Registration Number
- NCT01603979
- Lead Sponsor
- AVEO Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- ≥ 18 years of age
- Histologically and/or cytologically confirmed primary diagnosis
- Metastatic or advanced solid tumor, that has recurred or progressed following standard therapies, or for which no standard therapy exists
- Must have available tumor tissue or be willing to undergo biopsy prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Blood Chemistry and Hematology results within defined limits
Exclusion Criteria
- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent
- Current central nervous system (CNS) or leptomeningeal metastases, or history of CNS or leptomeningeal metastases.
- Significant conduction disturbance, history of a severe arrhythmia, or history of a familial arrhythmia
- Significant cardiovascular disease
- Significant thromboembolic or vascular disorders within prior 3 months
- Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results
- Known history of positive results for hepatitis C, hepatitis B, or human immunodeficiency virus.
- For female subjects, pregnancy or lactation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose-escalation AV-203 Monotherapy AV-203 dose-escalation of monotherapy AV-203 (an ERBB3 inhibitory antibody) by IV every two weeks
- Primary Outcome Measures
Name Time Method Incidence of AEs, SAEs and Dose-limiting Toxicities (DLTs) Ongoing throughout study. DLTs evaluated for first cycle of therapy. 1 cycle = 28 days
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of AV-203 pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose 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 Objective Response Rate (ORR) Within 28 days of first dose and every 8 weeks while on study Volume of Distribution (Vd) of AV-203 pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose 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 Time to Cmax (Tmax) of AV-203 pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Trial Locations
- Locations (1)
AVEO Clinical Site
🇺🇸San Antonio, Texas, United States