Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03673020 | Phase 1a Study to Evaluate Immunogenicity of ASV® | PHASE1 | COMPLETED | 3 | — | — | May 16, 2019 | Feb 3, 2021 | Dec 2, 2021 | 1 | United States |
Assessed by monitoring the frequency, duration, and severity of drug-related AEs by completing physical examinations and clinical evaluations; evaluating changes in vital signs; and laboratory blood and urine sample evaluations.
| Arm | Type | Description |
|---|---|---|
| ASV® AGEN2017 | EXPERIMENTAL | ASV® AGEN2017 + QS-21 Stimulon® Adjuvant Vaccine |
| Name | Type | Description |
|---|---|---|
| ASV® AGEN2017 + QS-21 Stimulon® adjuvant | BIOLOGICAL | Neoantigen Vaccine |
Inclusion Criteria: 1. Signed, written informed consent. 2. Age ≥18 years. 3. Diagnosis of solid cancer that has been completely resected, NED, and eligible for observation only as SOC yet remain at risk of relapse per Investigator discretion. These include subjects diagnosed with malignant melanom...