Table 2.

Secondary objectives

Secondary objective	Definition of objectives	Timepoint of objectives evaluation
Pharmacokinetics and biodistribution.	Determination of serum levels of IL-12 cytokine.	A follow-up examination according to clinical trial protocol (day 0, 3, 8 and 31).
Pharmacodynamics	Determination of tumor IL-12 and IFN-γ levels in tumor biopsies. Determination of plasmid DNA in tumor biopsies.	A follow-up examination according to clinical trial protocol (day 8 and 31).
Feasibility of recruitment	Evaluation the treatment of the and appropriateness follow up procedures. and execution of	During recruitment, execution of the treatment and follow up.
Determination of recommended dose for confirmatory studies	Measurement of pharmacodynamics data and selection of the phIL12 dose that produces IL-12 expression in the tumors with best biological activity, infiltration of the immune cells and no toxicity.	Based on all measurements during follow up.