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.