Exploratory Open Label Study of GM-CSF Coding Oncolytic Adenovirus CGTG-102, With Low Dose Cyclophosphamide in Patients With Refractory Injectable Solid Tumours
CGTG-102 is an adenovirus that has been armed with granulocyte-macrophage colony stimulating
factor (GMCSF), a potent stimulator of immunological cells.
With regard to oncolytic viruses, replication in normal cells does not take place, and
therefore viruses such as CGTG-102 are not known to cause any disease. Further, to date
there has been no incidence of passing the virus on to other humans from patients. Since the
virus requires tumor cells to multiply, such events are unlikely.
To this day more than 100 patients have been treated with CGTG-102. This clinical trial will
take place over approximately 6 months. The study includes 12 visits to the hospital, 1
screening visit, 9 injection visits including overnight stay at the hospital(performed on
trial days 1, 4, 8, 15, 29, 57, 85, 113 and 141), 1 end of treatment visit (day 169) and 1
end of study visit (day 190). Oral treatment with cyclophosphamide (1 pill per day) will
start on the day after the first injection and last until visit day 169.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the recommended phase II dose.
Mikael von Euler, MD PhD
Oncos Therapeutics Ltd.
Finland: Finnish Medicines Agency