COTC031: Novel Immune Therapy for Dogs with Lymphoma or Solid Tumors

Patient Disease:

Canine Lymphoma or Solid Tumor

Study Name:

COTC 031: Safety evaluation of ch45H1, a murine-canine chimeric anti-CTLA-4 monoclonal antibody, in tumor-bearing pet dogs

Purpose of the study:

  • To establish the safety, tolerability, and maximum tolerated dose (MTD) of a novel CTLA4-targeted chimeric antibody (ch45H1) when administered to canine patients with untreated or relapsed high-grade lymphoma or solid tumors

Primary Eligibility Criteria:

  • Weight at least 15 kg (33 lb) but no more than 60 kg (132 lb)
  • Histologically or cytologically confirmed diagnosis of lymphoma or solid tumor other than mast cell tumor, thyroid carcinoma, or cutaneous hemangiosarcoma
    • Tumor must be accessible for biopsy
  • Adequate blood work • Two-week washout from chemotherapy or radiation therapy, or 7-day washout from steroids or Lasparaginase
  • No concurrent immunomodulatory therapy or autoimmune disease
  • Pets must come to CSU for all visits related to the clinical trial

Study Protocol:

  • Prior to starting treatment, dogs will undergo lymph node aspirates, tumor biopsies, +/- bone marrow aspirate (lymphoma dogs only)
  • Study drug given as an IV infusion every 21 days for up to 4 doses
  • Visits required on Days 1, 8, 21-22, 29, 42-43, 63-64, 85, then every 8 weeks for physical exam, tumor measurements, blood work/urinalysis, and study blood collection; at some visits, lymph node aspirates and tumor biopsies +/- bone marrow aspirates will be performed; chest x-rays and abdominal ultrasound will be performed on Days 42, 85, and every 8 weeks; serial blood collections will occur on Days 1, 21-22, 42-43, and 63-64
  • Dogs will be withdrawn from the study if their disease progresses or they develop significant side effects

Owner Responsibilities:

  • You are responsible for the initial testing to determine study eligibility and any other tests recommended by your pet’s oncologist
  • You are expected to make and keep all appointments associated with the study

Financial Incentives:

  • All costs related to the study are covered, including the chest x-rays and abdominal ultrasound prior to enrollment and during the study, exam fees, blood and urine tests, lymph node aspirates, tumor biopsies, bone marrow aspirates, and the cost of the study drug
  • $1000 credit given to pet’s account at the VTH at time of study withdrawal to be put towards additional treatments

If you have further questions about any of our clinical trials, please submit an online consult form. Your consult will then be directed to our trials team. Requests are typically returned within 5 business days.

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