NCT01978964

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

Maintenance Therapy With ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients Who Have Previously Received ONT-10

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Cascadian Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open label phase 1b maintenance therapy study to evaluate the long-term safety, immunogenicity, and anti-tumor effects of repeat-dose vaccination with ONT-10 in patients who have demonstrated safety and clinical benefit on the original ONT-10-001 phase 1 study.

Detailed description

Open label Phase 1b maintenance therapy study to evaluate the long-term safety, immunogenicity, and anti-tumor effects 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. Patients must have previously been enrolled on the Phase 1 clinical trial ONT-10-001, completed all treatment and follow-up through at least 12 weeks, experienced no dose limiting toxicity, and experienced no progression of disease per the immune-related Response Criteria. Patients will receive maintenance ONT-10 every 6 weeks.

Conditions

• Solid Tumors

Interventions

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

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-11-08
• Last updated: 2018-05-17

Locations

1 site across 1 country: United States