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

NCT ID: NCT01603979

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-12-31

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose-escalation AV-203 Monotherapy

dose-escalation of monotherapy AV-203 (an ERBB3 inhibitory antibody) by IV every two weeks

Group Type: EXPERIMENTAL

AV-203

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AVEO Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AVEO Clinical Site

Scottsdale, Arizona, United States

AVEO Clinical Site

Atlanta, Georgia, United States

AVEO Clinical Site

San Antonio, Texas, United States

Countries

United States

Other Identifiers

AV-203-12-101

Identifier Type: -

Identifier Source: org_study_id