A Phase II, Single Arm, Investigative Study of IMM-101 in Combination With Radiation Induced Tumour Necrosis in Patients With Previously Treated Colorectal Cancer

Patients are eligible to be included in the study if they:

1. Are male or female; aged ≥ 18 years.
2. Have a histologically confirmed colorectal adenocarcinoma.
3. Have documented evidence of disease progression following at least one line of chemotherapy.
4. Have no further standard chemotherapy options available have refused further chemotherapy.
5. Have metastatic lesions in at least two sites in the liver (+/- other sites) suitable for bidimensional and volumetric evaluation by CT scan.
6. Have WHO performance status of 0-2.
7. Have a Cockcroft calculated Glomerular Filtration Rate of > 40mL/min at screening.
8. Have a life expectancy, in the opinion of the Investigator, of > 3 months from screening.

Patients are not eligible if one or more of the following statements are applicable:

1. Patient has evidence of central nervous system metastasis.
2. Patient has severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments.
3. Patient has any previous or concurrent malignancy, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non-melanoma skin cancer, or if previous malignancy was more than 5 years earlier and there are no signs of recurrence.
4. Patient has serum albumin < 30 g/L at screening.
5. Patient has a C-reactive protein (CRP) > 70 mg/L at screening.
6. Patient has transaminases (ALT or AST) > 5 X Upper Limit of Normal at screening.
7. Patient has a bilirubin level > 2 X Upper Limit of Normal at screening.
8. Patient has had radiotherapy in the 12 weeks before screening.
9. Patient has used depot corticosteroids in the 6 weeks before screening.
10. Patient has had chronic use of any systemic corticosteroids (> 10 mg per day of prednisolone or equivalent for a period of 2 weeks or more) and/or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporin) within the 2-week period before the first administration of study drug.
11. Patient of child-bearing potential who is not using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]). Those patients that utilise hormonal contraceptives must have used the same method for at least three months before study dosing. Patients of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile.
12. Patient who is pregnant, breast feeding or planning a pregnancy during the course of the study. Where appropriate, a pre-treatment serum pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative.
13. Patient has been administered any investigational product in the 3 months before screening.
14. Contraindication to CT scan, e.g., allergy to iodine based contrast medium.
15. Patient has a surgical or medical condition which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
16. Patient has presence of any uncontrolled concomitant disease (e.g., unstable angina pectoris, congestive heart failure, myocardial infarction, cardiac arrhythmias, uncontrolled severe hypertension) which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
17. Patient has a history of serious adverse reaction or serious hypersensitivity to any drug that in the opinion of the Investigator may raise a safety concern.
18. Patient has had any previous treatment with IMM-101 or related mycobacterial immunotherapy (prior BCG vaccination against TB is allowed).
19. Patient is known to have a history of human immunodeficiency virus (HIV) or syphilis, current symptomatic Hepatitis B or C.
20. Patient is unable or unwilling to comply with the protocol.