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

Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

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

Radiotherapy given in standard fractionation regimes leads to cell death by causing double
stranded DNA breaks via production of oxygen free radicals. At the very high doses of
stereotactic body radiotherapy (SBRT) administered with extreme accuracy in a single
fraction by the CyberKnife system, there is induction of tumour necrosis due to endothelial
cell damage and vascular collapse, cell membrane breakdown, and the release of cellular
material and tumour antigens into the circulation, in addition to DNA strand breaks. It is
hypothesised that the combination of modulation of the body's immune responses in the
presence of an increased exposure to tumour antigen will provide sufficient induction of the
immune system to suppress tumour growth.

Inclusion Criteria

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

4. Have no further standard chemotherapy options available have refused further

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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease stabilisation rate

Outcome Description:

The disease stabilisation rate at 24 weeks defined as the proportion of patients with a complete response, partial response or stable disease in accordance with immune-related response criteria.

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Andrew Gaya

Investigator Role:

Principal Investigator

Investigator Affiliation:

Leaders In Oncology Care, Harley St, London


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

February 2012

Completion Date:

August 2014

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms