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A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc. Identifier:
First received: May 21, 2012
Last updated: April 6, 2015
Last verified: April 2015
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.

Condition Intervention Phase
Solid Tumors
Biological: AV-203
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label, Multiple Dose, Dose Escalation Study of Monoclonal Antibody AV-203 Administered in Subjects With Metastatic or Advanced Solid Tumors

Further study details as provided by AVEO Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose-escalation AV-203 Monotherapy
dose-escalation of monotherapy AV-203 (an ERBB3 inhibitory antibody) by IV every two weeks
Biological: AV-203
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01603979

United States, Arizona
AVEO Clinical Site
Scottsdale, Arizona, United States, 85258
United States, Georgia
AVEO Clinical Site
Atlanta, Georgia, United States, 30322
United States, Texas
AVEO Clinical Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
AVEO Pharmaceuticals, Inc.
  More Information

Responsible Party: AVEO Pharmaceuticals, Inc. Identifier: NCT01603979     History of Changes
Other Study ID Numbers: AV-203-12-101
Study First Received: May 21, 2012
Last Updated: April 6, 2015

Keywords provided by AVEO Pharmaceuticals, Inc.:
Solid Tumors
Monoclonal Antibody

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017