Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT03673020
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1a Study to Evaluate Immunogenicity of ASV®
Sponsor:
Agenus Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: