NCT03673020

Phase 1a Study to Evaluate Immunogenicity of ASV®

Phase 1a First-in-Human Study of Safety and Tolerability of ASV® AGEN2017 With QS-21 Stimulon® Adjuvant as a Single Agent in Subjects With Solid Tumor at Risk of Relapse Undergoing Observation as SOC Following Complete Surgical Resection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase 1a First-in-Human Study to determine Safety and Tolerability of ASV® AGEN2017 with QS-21 Stimulon® Adjuvant as a Single Agent in Subjects With Tumors at Risk of Relapse Undergoing Observation as Standard of Care Following Complete Surgical Resection.

Detailed description

This is a Phase 1a study to evaluate neoantigen vaccine, AutoSynVax (ASV®) AGEN2017 in subjects with resected solid tumors, no evidence of disease (NED), and with an estimated life expectancy of ≥12 months from the time tissue has been submitted for vaccine manufacture. A minimum of 3 subjects will be enrolled to receive every two weeks subcutaneous injection of AGEN2017 + QS-21 adjuvant.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	ASV® AGEN2017 + QS-21 Stimulon® adjuvant	Neoantigen Vaccine

Timeline

• Start date: 2019-05-16
• Primary completion: 2021-02-03
• Completion: 2021-02-03
• First posted: 2018-09-17
• Last updated: 2021-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study