NCT01556789

Phase 1 Study of ONT-10 in Patients With Solid Tumors

Phase 1 Study of ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Cascadian Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	ONT-10	ONT-10 a liposomal synthetic glycolipopeptide antigen formulated with PET Lipid A adjuvant.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-05-01
• Completion: 2015-09-01
• First posted: 2012-03-16
• Last updated: 2018-05-17

Locations

3 sites across 1 country: United States