Pancreas Cancer, Pancreatic Cancer, Pancreatic Cancer Stage IV, Pancreatic Cancer Stage III
Conditions
Brief summary
An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.
Detailed description
IMM-101 is a suspension of heat-killed whole cell Mycobacterium obuense. Since it is a heat-killed preparation, treatment is not associated with the potential side-effects of delivering live or attenuated organisms. Five studies with IMM-101 have been completed including a 110-patient randomised Phase II study in pancreatic cancer and exploratory studies in other solid tumours (melanoma, colorectal cancer and advanced melanoma).
Interventions
BIOLOGICALIMM-101
IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline. The treatment regimen with IMM-101 is one dose given every 2 weeks for three doses followed by 4 weeks rest, then one dose is given every 2 weeks for a further three doses. Subsequent doses are given every 4 weeks.
Sponsors
Immodulon Therapeutics Ltd
Impatients N.V. trading as myTomorrows
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
This Expanded Access Program is available for patients of 18 years or older with advanced pancreatic cancer for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable.
Exclusion criteria
Female patient of child-bearing potential who is not, in the opinion of the physician, using an approved method of birth control (e.g., physical barrier \[patient and partner\], contraceptive pill or patch, spermicide and barrier, or intrauterine device \[IUD\]).
Countries
France, United Kingdom
Outcome results
None listed