Metastatic colorectal cancer MedDRA version: 14.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Mycobacterium obuense
Product Code: IMM-101
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Mycobacterium obuense
Sponsors
Immodulon Therapeutics Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 or the patient has 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. 9. Provide written informed consent to participate as shown by a signature and date on the patient's informed consent form (ICF). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of IMM-101 in combination with radiation induced tumour necrosis (induced by CyberKnife treatment) in patients with colorectal cancer with metastatic disease who have received prior chemotherapy.; Secondary Objective: To investigate the safety and tolerability of IMM-101 in combination with radiation induced tumour necrosis (induced by CyberKnife treatment) in patients with colorectal cancer with metastatic disease who have received prior chemotherapy To conduct an eploratory investigation of selected markers of tumour burden and immunological status in patients with colorectal cancer with metastatic disease treated with IMM-101 and radiation induced tumour necrosis (induced by CyberKnife treatment). ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Objective response rate at 12, 24, 36 and 48 weeks Disease stabilisation rate at 12, 36 and 48 weeks Overall disease stabilisation rate Overall response rate Progression-free survival at 12, 24, 36 and 48 weeks Survival at 12, 24, 36 and 48 weeks Tumour Markers at 12, 24, 36 and 48 weeks ;Timepoint(s) of evaluation of this end point: 12, 24, 36 and 48 weeks | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Administrator
Immodulon Therapeutics Ltd
Outcome results
None listed