Phase I/II clinical trial of ColoAd1 by sub-acute fractionated IV dosing in cancer patients

Primary objectives: Phase I: - To evaluate the safety and tolerability of ColoAd1, when administered by sub-acute fractionated IV injection to patients with advanced or metastatic epithelial solid tumours not responding to standard therapy or for whom no standard treatment exists- To determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of ColoAd1 when administered by sub-acute fractionated intravenous (IV) injection to patients with advanced or metastatic epithelial solid tumours not responding to standard therapy or for whom no standard treatment exists, and to recommend a dose for phase II studies.
Phase II:- To evaluate the progression free survival (PFS) in patients with metastatic colorectal cancer, who receive ColoAd1 administered by sub-acute fractionated IV injection as an intensification of first line chemotherapy compared with first line chemotherapy alone.
Primary endpoints: Phase 1: Safety and tolerabilityDetermine a maximum tolerated dose (MTD) / maximum feasible dose (MFD) of ColoAd1 when administered by sub-acute fractionated IV injection (phase I Dose Escalation) and a recommended dose for phase II studies
Phase 2: Rate of Progression-Free Survival (PFS) at 24 weeks, defined as the rate of patients being free from clinical/radiological progression and alive within the week 24 time window from randomisation as determined by an independent review committee.