Phase 1 Study of ONT-10 in Patients With Solid Tumors
Open label, two part, Phase 1 dose escalation study to evaluate the safety and immunogenicity of repeat dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid tumors. Part 1 to evaluate escalating dose levels of ONT-10 administered subcutaneously every two weeks (Q2W) or weekly (QW) over 8 weeks. Part 2 evaluates the safety, immunogenicity, and potential anti-tumor activity of ONT-10 administered over 8 weeks at the Q2W and QW maximum tolerated does/recommended dose (MTD/RD) in cohorts of 15 patients each.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Study of ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients With Solid Tumors|
- Safety [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]Assessment of adverse events and laboratory abnormalities
- Immunogenicity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]Assessments to include evaluation of humoral and cellular immune response.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: ONT-10 Vaccine
ONT-10 investigational agent
ONT-10 a liposomal synthetic glycolipopeptide antigen formulated with PET Lipid A adjuvant.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556789
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|United States, Texas|
|Mary Crowley Cancer Research Center|
|Dallas, Texas, United States, 75201|
|United States, Washington|
|Northwest Medical Specialties, PLLC|
|Tacoma, Washington, United States, 98405|
|Study Chair:||Diana Hausman, MD||Oncothyreon Inc.|