IMM-101-001

• Research type

  Research Study

• Full title

  An intra-patient placebo-controlled, Phase I clinical study, to evaluate the safety and tolerability of intra-dermal IMM-101 (heat-killed Mycobacterium obuense) in adult melanoma cancer patients.

• IRAS ID

  23959

• Contact name

  Angus Dalgleish

• Eudract number

  2009-012447-42

• ISRCTN Number

  NA

• Research summary

  The purpose of this study is to look at the safety of a new immunotherapeutic agent which is intended to be used alongside standard of care to treat a variety of different cancers. We would like to see how well this immunotherapeutic agent is tolerated following multiple intradermal injections. The immunotherapeutic agent (IMM-101) is a heat- killed preparation of Mycobacterium obuense, which is a non-pathogenic (not harmful) type of bacterium found in the soil. We aim to recruit 18 patients and to evaluate the safety and tolerability of 3 doses of IMM-101.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/59

• Date of REC Opinion

  17 Nov 2009

• REC opinion

  Further Information Favourable Opinion