This inventory record must be available for inspection at any time by CRAs or CSMs of the Sponsor. AST-VAC2 supplies are to be used only in accordance with this protocol and under the supervision of the Investigator. CONFIDENTIAL CRUKD/17/003 Protocol Final 5.0 dated 08Jun2021 Page 33 of 72 EudraCT number : 2016 -002577 -35 Cancer Research UK Unus ed product (thawed or frozen) should be returned to pharmacy for destruction. The Investigator undertakes not to destroy any unused or returned AST-VAC2 unless authorised to do so by the Sponsor . Any unused AST -VAC2 must be destroyed according to hospital procedures and properly accounted for using the IMP Destruction Form and also on the IMP Accountability Record. During the course of the trial the CRA will check the numbers of vials of AST -VAC2 shipped to the centre, the number used and the number destr oyed. The pharmacy will give an account of any discrepancy. CONFIDENTIAL CRUKD/17/003 Protocol Final 5.0 dated 08Jun2021 Page 36 of 72 EudraCT number : 2016 -002577 -35 Cancer Research UK 7.1.3 Evaluations within 7 days of study enrolment The following must be performed within 7 days before study enrolment : • Female patients able to have children must have a negative result on a human chorionic gonadotropin (HCG) pregnancy test (serum or urine test is acceptable). • Complete physical examination; • Height, weight, WHO PS, • Vital signs ( temperature, seated BP and pulse rate) ; • ECG; • Laboratory tests (blood/urine samples) . Laboratory tests relating to specific eligibility criteria must be performed to confirm a patient’s eligibility prior to study enrolment : - Haematology – haemoglobin (Hb), white blood cells (WBC) with differential count (neutrophils , lymphocytes , platelets and eosinophils ). - Biochemistry – sodium, potassium, adjusted calcium, phosphate, urea, creatinine, total protein, albumin, bilirubin, alkaline phosphatase (ALP) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and C-reactiv e protein (CRP) . - CEA sample - Urinalysis – pH, glucose, protein and blood. - Baseline research bloods (Please see Section 8.0 ) Investigators must enrol the patient on the trial once confirmed as eligible (see Section 4.2 ) and prior to the patient’s first AST -VAC2 vaccination . 7.2 Evaluations during the trial Day of vaccination • Symptom- directed physical examination: if clinically indicated, a symptom- directed physical examination is to be performed on the day of each vaccination before AST-VAC2 administration. • WHO PS on the day of each vaccination. • Vital signs, temperature, seated BP, pulse rate: must be assessed within 15 mins before the vaccination and within 15 mins after the vaccination. • Adverse events and concomitant medications : At each visit, before each AST-VAC2 vaccination, an assessment of any AE experienced since the previous visit must be made by the Investigator, Research Nurse or suitably qualified member of the Investigator’s team. The start and stop dates of the AE together with the relationship of the event to AST-VAC2 must be recorded in the medical records. All AEs must be graded according to NCI CTCAE Version 4.02 and protocol specific ISR grading system (See Section 9.0 for further details regarding AE reporting requirements and ISR grading system). Any concomitant treatment must be recorded in the medical records. (See Section 9.0 for further details regarding AE reporting requir ements.) • COVID -19 vaccines: If a patient is administered a COVID -19 vaccination during the AST-VAC2 vaccination period, there should be an interval of 48 hours between the administration of the vaccines and they should be administered to different sites. The COVID -19 vaccine should be documented in the eCRF as a concomitant medication and any AEs should be assessed for causality to AST-VAC2 and the COVID -19 vaccination. • Laboratory tests: Haematology and biochemistry: Week 1 vaccination : laboratory tests must be repeated and reported prior to the first vaccination if the results used for enrolment purposes are >7 days prior to the day of vaccination. CONFIDENTIAL CRUKD/17/003 Protocol Final 5.0 dated 08Jun2021 Page 38 of 72 EudraCT number : 2016 -002577 -35 Cancer Research UK • Female patients ab le to have children must have a human chorionic gonadotropin (HCG) pregnancy test (serum or urine test is acceptable). • Radiological assessment of disease: This must be repeated at the end of the vaccination schedule. Tumour measurements must be documented according to Immune- Related Response Criteria (irRC). (Refer to Section 10.0).