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A Phase 1 Open-label, Multiple Dose, Dose Escalation Study of Monoclonal Antibody AV-203 Administered in Subjects With Metastatic or Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

A Phase 1 Open-label, Multiple Dose, Dose Escalation Study of Monoclonal Antibody AV-203 Administered in Subjects With Metastatic or Advanced Solid Tumors


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of AEs, SAEs and Dose-limiting Toxicities (DLTs)

Outcome Time Frame:

Ongoing throughout study. DLTs evaluated for first cycle of therapy. 1 cycle = 28 days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

AV-203-12-101

NCT ID:

NCT01603979

Start Date:

May 2012

Completion Date:

October 2014

Related Keywords:

  • Solid Tumors
  • AV203
  • Solid Tumors
  • ERBB3
  • Monoclonal Antibody
  • HER3
  • Neoplasms

Name

Location

AVEO Clinical SiteScottsdale, Arizona  85258
AVEO Clinical SiteAtlanta, Georgia  30322
AVEO Clinical SiteSan Antonio, Texas  78229