A Study of IMM-101 in Combination With Radiation Induced Tumour Necrosis in Colorectal Cancer

NCT01539824 | Completed Phase 2 Results DMC

• 2 other identifiers: IMM-101-0072011-003958-85
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to investigate the safety and effects of IMM 101 in combination with a single targeted dose of radiation in patients with metastatic colorectal cancer in whom chemotherapy or other treatment has not been effective. Administration of radiation (using the CyberKnife) to the target tumour growth in the liver results in the release of tumour material. IMM-101 may help the immune system to react to the tumour material released from the damaged tumour, and so have a beneficial effect in slowing down the rate of growth of other tumour growths in the liver and other organs.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Stabilisation Rate

  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.

  24 weeks

Secondary Outcomes (6)

• Safety and Tolerability Profiles

  48 weeks

• Objective Response Rate

  12, 24, 36 and 48 weeks

• Disease Stabilisation Rate

  12, 36 and 48 weeks

• Overall Disease Stabilisation Rate

  12, 36 and 48 weeks.

• Overall Response Rate

  12, 24, 36 and 48 weeks.

Study Arms (1)

IMM-101 plus SBRT

EXPERIMENTAL

The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason

Biological: Mycobacterium obuense; Radiation: SBRT

Interventions

Mycobacterium obuense BIOLOGICAL

IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.

Also known as: IMM-101

IMM-101 plus SBRT

SBRT RADIATION

The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.

Also known as: stereotactic body radiation, CyberKnife

IMM-101 plus SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female; aged ≥ 18 years. Histologically confirmed colorectal adenocarcinoma. Documented evidence of disease progression following at least one line of chemotherapy.
• No further standard chemotherapy options available have refused further chemotherapy.
• Metastatic lesions in at least two sites in the liver (+/- other sites) suitable for bidimensional and volumetric evaluation by CT scan.
• World Health Organization (WHO) performance status of 0-2. Cockcroft calculated Glomerular Filtration Rate of \> 40mL/min at screening. Life expectancy, in the opinion of the Investigator, of \> 3 months from screening.

You may not qualify if:

• Evidence of central nervous system metastasis. Severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments.
• 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.
• Serum albumin \< 30 g/L at screening. C-reactive protein (CRP) \> 70 mg/L at screening. Transaminases (ALT or AST) \> 5 X Upper Limit of Normal at screening. Bilirubin level \> 2 X Upper Limit of Normal at screening. Radiotherapy in the 12 weeks before screening. Depot corticosteroid use in the 6 weeks before screening. 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.
• Woman of child-bearing potential who is not using an approved method of birth control Any investigational product administration in the 3 months before screening. Contraindication to CT scan, e.g., allergy to iodine based contrast medium. 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.
• Any uncontrolled concomitant disease which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
• History of serious adverse reaction or serious hypersensitivity to any drug that in the opinion of the Investigator may raise a safety concern.
• Any previous treatment with IMM-101 or related mycobacterial immunotherapy (prior bacillus Calmette-Guerin (BCG) vaccination against Tuberculosis is allowed).
• Known history of human immunodeficiency virus (HIV) or syphilis, current symptomatic Hepatitis B or C.
• Unable or unwilling to comply with the protocol.

Sponsors & Collaborators

• Immodulon Therapeutics Ltd: lead

Study Sites (2)

HCA International, The Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

The London Clinic

London, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

IMM-101; Radiosurgery

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

The success criteria for the study as a whole, including progression to the second stage, were challenging. With hindsight, a larger sample size facilitating analysis of a less demanding, but still clinically meaningful, treatment effect might have been more appropriate and would be recommended for any future similar investigations.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Immodulon Therapeutics Ltd

info@immodulon.com

+44 (0)20 3137 6346

Study Officials

• Andrew Gaya

  Leaders In Oncology Care, Harley St, London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: February 28, 2012
• Study Start: May 30, 2012
• Primary Completion: March 27, 2014
• Study Completion: March 27, 2014
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)