A Phase I Study of the Chimeric Anti-CD40 Monoclonal Antibody ChiLob 7/4 to Treat Advanced Malignancies Refractory to Conventional Anti-cancer Treatment

Exclusion Criteria

• •CD40 negative tumours by immunohistochemistry.
• •Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas and mitomycin-C) prior to treatment.
• •All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient.
• •Pregnant and lactating women are excluded.
• •Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
• •Patients with primary brain tumours or clinically apparent brain metastases.
• •Patients who are high medical risks because of non-malignant systemic disease including active uncontrolled infection.
• •Patients with any other condition which in the Investigator"s opinion would not make the patient a good candidate for the clinical trial.
• •Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
• •Long term immunosuppression or steroids (for more than one month)
• •History of significant and serious allergy.
• •Concurrent congestive heart failure or prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\] - refer to Appendix 4)
• •Patients with low grade or transformed non-Hodgkin"s lymphoma.
• •Prior treatment with murine monoclonal antibodies. (Prior treatment with chimeric or fully human antibodies will not exclude a patient).
• •A history of clinically significant autoimmune disease.
• •Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.