IMM-101-012 v1.0
Research type
Research Study
Full title
A Long Term Safety Study for Patients Who Have Previously Been Treated with IMM 101 on a Named Patient Basis
IRAS ID
222448
Contact name
Andrew Gaya
Contact email
Sponsor organisation
Immodulon Therapeutics Ltd
Eudract number
2016-002948-16
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
The purpose of this study is to provide information on the long term safety and tolerability of IMM-101.
IMM-101 contains a bacterium (Mycobacterium obuense) that has been killed at high temperature so that it is not infectious but can still produce effects on the immune system.
Patients with metastatic or unresectable cancer who are receiving IMM-101 on a 'Named Patient' basis under the UK Medicines Regulations are the target population for this study.
Patients enrolled in the trial will continue to receive IMM-101 alone or in combination with a systemic therapy and/or radiotherapy regimen, which the Investigator considers appropriate for the patient's specific tumour type.
Patients will receive ongoing treatment with IMM-101 at a nominal 4 week interval unless the dose given and/or the interval has been modified at the discretion of the prescribing physician for safety or tolerability reasons during Named Patient use. In these cases, the dose and/or dose interval previously established for each individual patient will be continued at study entry.
It is anticipated that the duration of this open label study will be approximately 5 years.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0807
Date of REC Opinion
2 Jun 2017
REC opinion
Unfavourable Opinion