Peter Johnson research projects
University of Southampton
Southampton Cancer Research UK Centre
Somers Cancer Research Building, MP824
Southampton General Hospital
CRUKD/07/063: A Cancer Research UK Phase I trial of the chimeric anti-CD40 monoclonal antibody Chi Lob 7/4 given iv weekly for 4 weeks in advanced malignancies refractory to conventional cancer treatmentFunding period: 01 April 2003 to 30 April 2016
Funding scheme: New Agents Committee Trials Funding
Funding committee: New Agents Committee
This is a Cancer Research UK Phase I clinical trial evaluating the safety, tolerability and biological effects of the chimeric anti-CD40 monoclonal antibody Chi Lob 7/4 given intravenously, weekly for 4 weeks in the treatment of patients with advanced malignancies refractory to conventional anti-cancer treatment. Patients with CD40 positive solid tumours or diffuse large B-cell non-Hodgkin's lymphoma will be entered into the trial. It is a 2 centre, dose escalation, Phase I study.
Specific aims and objectives
The primary objectives of the trial are: to establish the maximum tolerated dose (MTD) of Chi Lob 7/4; to determine the biologically active dose; to determine and establish the toxicity profile of Chi Lob 7/4 and to identify the dose limiting toxicity (DLT); and to propose a safe dose for Phase II evaluation.
The secondary objectives are: to examine the biological effects of Chi Lob 7/4 treatment; to examine the pharmacokinetics (PK) of treatment using ELISA measurement of serum Chi Lob 7/4 levels; and to examine any anti-tumour activity. If no dose-limiting toxicity (DLT) is observed after all patients have completed the study, the biologically active dose will be determined as that at which peripheral blood B-cells are reduced by the end of therapy (4 weeks post last infusion) to 10% or less of the starting number.
Secondary end-points will include plasma cytokine levels, analysis of tumour infiltrating lymphocytes/mononuclear cells, and circulating APCs.