Phase 1 Study of ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients With Solid Tumors
This open label, two part, Phase 1 dose escalation study will evaluate the safety and
immunogenicity of repeat dose vaccination with ONT-10 in patients with previously treated
Stage 3 or 4 solid tumors with histologies that have been associated with expression of the
MUC1 antigen as described in the medical literature. Part 1 will evaluate escalating dose
levels of ONT-10 administered subcutaneously Q2W over 8 weeks (for a total of 4 doses) or QW
over 8 weeks (for a total of 8 doses) to identify a MTD and/or RD for each dosing schedule,
for further evaluation in Part 2 of the study. Part 2 will evaluate the safety,
immunogenicity, and potential anti-tumor activity of ONT-10 administered over 8 weeks at the
Q2W and QW MTD/RD in cohorts of 15 patients each.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety
Assessment of adverse events and laboratory abnormalities
20 weeks
Yes
Diana Hausman, MD
Study Chair
Oncothyreon Inc.
United States: Food and Drug Administration
ONT-10-001
NCT01556789
March 2013
June 2014
Name | Location |
---|---|
Mary Crowley Cancer Research Center | Dallas, Texas 75246 |