National Cancer Institute - Cancer.gov

COTC031a/b/c: Safety evaluation of three anti-canine CTLA-4 monoclonal antibodies in tumor-bearing dogs

Background and Purpose

The purpose of this study is to evaluate three types of a cancer treatment called a monoclonal antibody. Antibodies are normally present in the immune system and can bind to proteins which blocks their function. These treatments target a protein called CTLA-4, which is often present on cancer cells and helps the cancer to hide from the immune system. By giving a cancer patient an antibody that attaches to and blocks the function of CTLA-4, the immune system can better recognize and fight the cancer.

Monoclonal antibodies are regularly used in human cancer treatments. All three of the treatments in this study work the same way, however each has a different structure, which may lead to differences in how they work and how effective they are. The treatments are called ch45H1, CaAb4-2, and VGS-001.

We know that by studying dogs with cancer, we can better understand how cancer effects both dogs and people, and potentially improve cancer treatment. The goal of this study is to choose one of these three treatments that is safe in dogs and is shown to be able to improve the immune system’s response to cancer. The monoclonal antibody that is chosen will be able to be used in future studies.

Study Locations

Participation Criteria

There will be up to 90 dogs taking part in this study across North America.

  • Dogs weighing more than 15kg (33 lbs) who have been diagnosed with cancer.
  • Patients can have received other treatment for their cancer, but will need to stop treatment up to two weeks before the study.

Study Details

  • Before your pet begins the study, your pet will need to have the following tests and/or procedures to find out if he/she can be in the study: bloodwork, urinalysis, chest x-rays, and abdominal ultrasound. If a diagnosis has not been made, additional diagnostic tests such as a fine needle aspirate or biopsy may be required to determine a diagnosis. These tests are routinely performed prior to considering treatment for dogs with cancer.
  • If the exams, tests, and procedures show that your pet can take part in the study, and you choose to enroll them, then the following will happen as part of the study:
    • Blood work and a biopsy of your pet’s tumor will be taken before any treatment with the medication.
    • Your pet will receive one of the treatments (ch45H1, CaAb4-2, or VGS-001) by IV (infusion into the vein) once every three weeks for four doses. After each treatment they will be monitored for 6 hours to ensure there are no immediate side effects.
    • At each visit, blood work will be collected to ensure your pet is tolerating the treatment well.
    • One week after the second dose (Day 29) your pet will return for a biopsy of their tumor.
    • On the day before the 3rd dose (Day 42), your pet will have chest x-rays and abdominal ultrasound to ensure their cancer is not getting worse.
    • Three weeks after the 4th dose (Day 85), your pet will be evaluated with blood work, chest x-ray, and abdominal ultrasound, and a biopsy of the tumor will be taken.
    • If your pet’s cancer is responding to the medication or if it has not grown on Day 85, you and your pet will be asked to return every two months for up to a year to monitor their cancer.
    • If your pet’s cancer stays the same or continues to get better over the year-long period, they will have a biopsy of their tumor (if a biopsy can be performed) before leaving the study.
    • If your pet’s cancer gets worse at any time during the year-long period, their doctor will take a biopsy if it is safe to do so, and your pet can then leave the study and receive other cancer treatment.

Contact Information

Please contact the nearest study site if you’re interested in seeing if your dog is eligible to participate.