Table 2.
Clinical trials of neoantigen-DNA vaccines.
| Trial No. (Brand Name) |
Target | Indication | Format/Route of Administration | Combination Therapy | Status |
|---|---|---|---|---|---|
| NCT03122106 | Personalized NeoAg + Mesothelin | Pancreatic Cancer | Plasmid DNA/Electroporation + IM injection | N/A | Phase 1, Active, Not Recruiting |
|
NCT04015700 (GNOS-PV01) |
Personalized NeoAg | Unmethylated Glioblastoma | Plasmid DNA/Electroporation + IM injection | Pembrolizumab, Plasmid encoded IL-12 (INO-9012) |
Phase 1, Recruiting |
|
NCT04251117 (GNOS-PV02) |
Personalized NeoAg + Mesothelin | HCC | Plasmid DNA/Electroporation + IM injection | Pembrolizumab, Plasmid encoded IL-12 (INO-9012) |
Phase 1/2a, Recruiting |
|
NCT04990479 (Nous-PEV) |
Personalized NeoAg | Melanoma, NSCLC |
Adenovirus vector + Vaccinia virus vector/IM injection | Pembrolizumab | Phase 1, Recruiting |
|
NCT04041310 (Nous-209) |
Personalized NeoAg | MSI-H CRC, gastric, G-E junction tumors |
Adenovirus vector + vaccinia virus vector/IM injection | Pembrolizumab | Phase 1/2, Active, Not Recruiting |
|
NCT05018273 (VB10.NEO) |
Personalized NeoAg | Solid Tumors | Plasmid DNA/IM injection | Atezolizumab | Phase 1b, Recruiting |
| NCT02348320 | Personalized NeoAg | Triple-Negative Breast Cancer | Plasmid DNA/Electroporation + IM injection | N/A | Phase 1, Completed |
|
NCT03953235 (SLATE) |
Shared Neoantigen |
Shared neoantigen positive tumors | Adenovirus vector + RNA vector/Not specific | Nivolumab, Ipilimumab |
Phase 1/2, Recruiting |
|
NCT03265080 (ADXS-NEO) |
Personalized NeoAg | Colon Cancer, Head & Neck Cancer, NSCLC, Urothelial Carcinoma, Melanoma |
Lm-based vector/I.V. infusion | Pembrolizumab (selectively) |
Phase 1, Active, Not Recruiting |
|
NCT03847519 (ADXS-503) |
Personalized NeoAg | NSCLC, Metastatic SCC, Metastatic NSCLC |
Lm-based vector/I.V. infusion | Pembrolizumab (selectively) |
Phase 1/2, Recruiting |
Abbreviations: CRC, colorectal cancer. HCC, hepatocellular carcinoma. I.V., intravascular infusion. I.M., intramuscular injection. Lm, Listeria monocytogenes. MSI-H, high microsatellite instability. NSCC, small-cell lung cancer. NSCLC, non-small-cell lung cancer.