Cancer Immunotherapy: Phase 1 trial for a new canine immunotherapy drug (TriKE)
Amber Winter, CVT
Research Professional 2
[email protected]
612-624-1352
Study title
Safety and activity of a new immunotherapy drug (Phase 1 trial) for dogs with various cancers
Purpose of study
The purpose of the study is to evaluate the dose, timing, anti-tumor effects and potential side effects of a new immunotherapy drug designed for dogs, called a “TriKE”.
Eligibility criteria
- We are most interested in enrolling dogs that have a biopsy confirmed soft tissue sarcoma or osteosarcoma. Because we want to know what dose to use in dogs, we will also enroll dogs with some carcinomas and oral melanomas.
- Visible (large tumors) or microscopic (surgical scars without visible tumor) tumors
- Weight is > 7 kg (15 lbs)
- No significant co-morbidities that affect heart, lung, kidney, or liver function
- Not currently receiving chemotherapy, immunotherapy or radiation treatment
- Clients must return to the University of Minnesota for all visits over the course of the study (~ 5-6 weeks)
Procedures
For dogs enrolled in the study, there are 9-10 visits planned during this trial. Baseline evaluation will consist of a physical exam, blood and urine collection for analysis, and tumor measurement and samples (if there is a visible tumor).
Dogs will then be treated with a planned 6 doses of immunotherapy that is given by a subcutaneous (under the skin; SQ) injection twice a week for 3 weeks. During this time and for 2 weeks following the last treatment, we will reassess blood and urine samples in all dogs. If there is visible tumor, we will measure and resample the tumor (if possible) to analyze the cells.
Dogs may then go on to receive other treatments following completion of the trial, if indicated by the pet’s oncology team.
Costs
The dog’s owner is responsible for costs associated with diagnosis and staging to allow enrollment. Once enrolled, the study will pay for all costs associated with treatment and monitoring.