Spots Global Cancer Trial Database for Phase 1b Maintenance Therapy Study of ONT-10 in Patients With Solid Tumors

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Trial Identification

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

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

Study ID: NCT01978964

Conditions

Solid Tumors

Interventions

ONT-10

Study Description

Brief 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.