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NCT Number: NCT01603979

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

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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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AVEO Clinical Site, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. Maximum Plasma Concentration (Cmax) of AV-203

    Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose

  2. Time to Cmax (Tmax) of AV-203

    Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose

  3. Area Under Plasma Concentration (AUC) of AV-203

    Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose

  4. 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

  5. Clearance (Cl) of AV-203

    Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose

  6. Volume of Distribution (Vd) of AV-203

    Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose

  7. Objective Response Rate (ORR)

    Time frame: Within 28 days of first dose and every 8 weeks while on study

  8. Disease Control Rate (DCR)

    Time frame: Within 28 days of first dose and every 8 weeks while on study

  9. Duration of Response (DOR)

    Time frame: Within 28 days of first dose and every 8 weeks while on study

  10. Time to Progression (TTP)

    Time frame: Within 28 days of first dose and every 8 weeks while on study

Sponsors and collaborators

Lead sponsor

AVEO Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 23, 2012
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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