Clinical Trial VICCTHN1324
A Phase 1/1b Open-Label, Dose-Escalation Study of Monoclonal Antibody AV-203 Administered as Monotherapy in Subjects with Metastatic or Advanced Solid Tumors or in Combination with Cetuximab (Erbitux?) in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Protocol No. VICCTHN1324
- Open Date: 09/16/2013
- Staging: Phase I
- Age Group: Adults
- Scope: National
- Objective: To evaluate the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AV-203 in subjects with metastatic or advanced solid tumors.
- Disease Sites:
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01603979
- Secondary Protocol No: AV-203-12-101
Patients are being asked to take part in this research study because they have a solid tumor that has either worsened following treatment or has returned (recurred) after treatment, and ytheir cancer is thought to be in a later stage or has spread to other areas of their body OR there are no standard therapies for their disease that are likely to help them. The main goals of this study are to find the highest dose of AV-203 that can be given safely without severe side effects when AV-203 is given alone and when AV-203 is given with cetuximab.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• ≥ 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
• 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.