Emerging Immunotherapy Study
SHP-1 Inhibitor (M029) Phase I Clinical Trial in Dogs with Cancer
Principal Investigators
Dr. Marejka Shaevitz and Dr. Debbie Knapp, Purdue University College of Veterinary Medicine
Background
The immune system has a natural ability to recognize and attack cancer cells, but cancers can use several mechanisms to reduce this immune response. M029 is a new oral immunotherapy drug that blocks SHP-1, a protein that can limit immune system activity. By blocking SHP-1, researchers hope that M029 may allow the immune system to better recognize and attack cancer cells.
M029 has been well tolerated in laboratory dogs, but this is the first clinical trial of M029 in pet dogs with naturally occurring cancer. The main goals of this Phase I study are to evaluate the safety of M029, learn how the drug moves through the body, determine whether it is having the expected effect on its target, and identify a dose that produces a biological effect. We will also look for any signs of anti-cancer activity in dogs receiving the drug.
Because M029 is a new, first-in-class drug, there may be side effects that are not yet known. Possible side effects include stomach upset and effects from an overactive immune system, such as inflammation of organs or worsening of an underlying autoimmune disease. Dogs enrolled in the trial will be monitored closely for these and other possible side effects.
M029 is given by mouth once daily. The dose will be gradually increased if the dog tolerates treatment well. Dogs will return to Purdue Veterinary Hospital Oncology every two weeks at first and then monthly for examinations, bloodwork, tumor measurements, and other monitoring. Some visits will last most of the day because several blood samples will be collected to measure drug levels and the drug's effects in the body.
Eligibility for Dogs to Participate in the Study
Dogs may be eligible if they:
- Are at least 1 year old and weigh at least 10 kg (22 pounds)
- Have a cancer diagnosis confirmed by cytology or biopsy
- Have a tumor that can be measured during a physical examination or on x-rays
- Have not yet received treatment for their cancer
- Are otherwise healthy and expected to live at least 18 weeks
- Can take oral medication at home on an empty stomach
Exclusion Criteria
Dogs may not be eligible if they have:
- A history or evidence of autoimmune disease
- Certain endocrine, heart, or other significant diseases
- Received chemotherapy or radiation therapy within the previous 3 months
- Previously received immunotherapy
- Recently received steroids, NSAIDs, herbal products, CBD, or other supplements
Final eligibility will be determined by the study team after review of the dog's medical history and screening results.
Financial Support
M029 is provided at no cost to owners. Owners are responsible for the costs of initial cancer diagnosis and staging before enrollment. Once enrolled, owners pay a flat fee of $350 per month to help cover bloodwork and study monitoring.
If an emergency visit is required because of a suspected treatment-related side effect, the study may provide up to $500 toward the cost of that visit. The study will also cover the cost of a necropsy if a participating dog dies or is euthanized.
Trial Status
Actively Recruiting
Questions
For more information about the SHP-1 clinical trial or to find out whether your dog may be eligible, please contact Dr. Marejka Shaevitz or the Clinical Trial Technician Holly Aschliman by calling 765-494-1107.
