IMM-101 in patients with metastatic cancer or unresectable cancer
Research type
Research Study
Full title
A Novel Phase I/IIa Open label Study of IMM-101 in Combination with Selected Standard of Care (SOC) Regimens in Patients with Metastatic Cancer or Unresectable Cancer at Study Entry
IRAS ID
211244
Contact name
David Cunningham
Contact email
Sponsor organisation
Immodulon Therapeutics Ltd
Eudract number
2016-001459-28
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Patients with metastatic cancer or cancer that cannot be completely removed through surgery, who are being considered for a new line of recognised standard of care chemotherapy (first, second and third line, and beyond), and with a life expectancy of greater than 3 months, are the target population for this study.
Patients enrolled in the trial will receive their standard of care chemotherapy, plus the investigational drug IMM-101. IMM-101 contains a specific organism (Mycobacterium obuense) that has been killed at high temperature so that it is not infectious, but still can produce immunological effects.
Patients will receive IMM-101 every 2 weeks for the first 3 doses, followed by a rest period of 4 weeks, then patients will receive IMM-101 every 2 weeks for the next 3 doses, and thereafter every 4 weeks for 6 months (28 weeks).
At Week 32, patients will progress to the Maintenance Phase of the study and will continue to be dosed every 4 weeks (or as close to this interval as permitted due to practical or logistical considerations). Patients will be followed up for assessment of safety, response to treatment and survival.
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/1784
Date of REC Opinion
8 Dec 2016
REC opinion
Further Information Favourable Opinion