Mechanism of Action Trial of ColoAd1

Inclusion Criteria

• •Patients must meet all the following criteria to be eligible for participation:
• •Able and willing to provide written informed consent and to comply with the study protocol
• •Age ≥ 18 years
• •Patients with histologically confirmed resectable colon cancer, NSCLC (squamous and non-squamous), bladder cancer (urothelial cell carcinoma) or RCC (renal cell carcinoma), scheduled for resection of primary tumour and with planned resection of draining lymph nodes for colon cancer
• •Diagnostic colonoscopy performed at the study centre (Cohorts A and B only) or a referral centre (Cohort B only) and a report from this colonoscopy available for the study
• •Tumour size of 3 cm or more in diameter as estimated during diagnostic colonoscopy for cohorts A and B or by CT-scan for cohorts C, D and E.
• •At least 2 weeks since the last dose of any intravenous systemic chemotherapy at time of first administration of ColoAd1
• •Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
• •Able to undergo surgery with general anaesthesia
• •Surgery planned and administration of ColoAd1 feasible within
• •* 15 days of planned surgery (following IT administration or following first dose of IV administration) for cohorts A and B
• •* 10 - 25 days of first ColoAd1 administration for cohorts C, D and E
• •ECOG Performance Status Score of 0 or 1
• •Adequate renal function
• •* Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula ≥ 60 mL/min, or measured creatinine clearance ≥60 mL/min,
• •* Absence of clinically significant haematuria on urinalysis: dipstick \< 2+
• •* Absence of clinically significant proteinuria on urinalysis: dipstick \< 2+.
• •Adequate hepatic function
• •* serum bilirubin \<1.5 x ULN
• •* AST and ALT ≤ 3 x ULN
• •Adequate bone marrow function:
• •* ANC ≥ 1.5 x 109/L,
• •* platelets ≥ 100 x 109/L,
• •* haemoglobin ≥ 90 g/L
• •Adequate coagulation tests: INR ≤ 1.5 x ULN;
• •For females of childbearing potential (defined as \<2 years after last menstruation or not surgically sterile), a negative pregnancy test must be documented prior to enrolment;
• •For women who are not postmenopausal (24 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, including at least one method with a failure rate of \< 1% per year (e.g., hormonal implants, combined oral contraceptives, vasectomized partner), during the treatment period and for at least 3 months after the last dose of study drug;
• •For men: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of study drug