CosMyc 01 (Canine Oncology Study of Myc inhibition: Pharmacokinetics and short-term tolerability of a novel peptide myc inhibitor in dogs with cancer)
Currently EnrollingSummary of Study:
The MYC gene plays a role in many types of cancer. However, this gene and its effects were once thought to be impossible to target with therapy. Recent advances have changed this paradigm and made this a viable target for therapy. The purpose of this study is to determine if a novel MYC inhibitor can be safely and effectively given to dogs at doses that will fight cancer.
This is a prospective, multicenter, dose finding and tolerability study
At least 30 dogs will be treated with OMO-103 delivered IV over 30-45 min weekly for a 28-day period. Some dogs will be selected for additional blood sampling and biopsies and will also receive additional compensation for this added participation.
Inclusion Criteria:
- Any dog with a recent diagnosis of cancer; dogs can be post-surgery as long as they have a recent diagnosis of malignancy.
- 10 dogs enrolled in cohorts 3-5 will be required to have biopsy and additional blood sampling. These dogs will need to have a tumor that can be easily biopsied. These dogs will receive pretreatment and post- treatment biopsies and will also receive additional compensation of $1,500 towards their bill for additional therapy.
- Dogs weighing >10 kg
Exclusion Criteria:
- Dogs that have received chemotherapy (including systemic corticosteriods) within 7 days of study entry
- Significant hepatic or renal disease (IRIS Stage 2 or higher)
- Creatinine > 1.4 mg/dL
- Bilirubin > 0.4 mg/dL or ALT > 400 U/L
- Modified ECOG performance status >1
- No concurrent medications or supplements with anticancer properties
Study Procedures:
OMO-103 will be administered IVweekly for 4 weeks. Infusions will be given over 30-45 min.
After confirmation of eligibility and signing of the consent form, dogs will receive a physical exam and blood workbefore drugadministration.Dogs will be given medications such as anti-histamines 20 minutes before infusion to prevent any infusion reactions.
Financial incentives:
The study will pay for the following costs: All exam fees and diagnostics associated with the study and up to of $3,000 per event. Dogs participating in the pharmacokinetic study will have all costs associated with the two biopsies and additional blood sampling covered by the study and they will receive an additional $1500 hospital credit towards their future care
Interested?
Enroll or request more information below.