Table 2.
Clinical trials in which neo-antigen mRNA is an investigational medicinal product. Abbreviations: i.d., intradermal; i.m., intramuscular; i.n., intranodal; i.v., intravenous; LNP, lipid nanoparticle; NA, not applicable; NN, not known, NSCL, non-small cell lung cancer; s.c., subcutaneous; TAA, tumor-associated antigen; TNBC, triple negative breast cancer.
| Cancer Type | Study | Phase | Formulation | Route | Other Therapy | Response |
|---|---|---|---|---|---|---|
| TNBC | NCT02316457 | Phase I | LNP | i.v. | NA | Study extended |
| Melanoma | NCT02035956 | Phase I | Naked mRNA | i.n. | RBL001/RBL002 | Not published |
| NSCLC | NCT03164772 | Phase I/II | LNP | i.d. | Durvalumab, Tremelumumab | Study ongoing |
| Solid tumors | NCT03289962 | Phase I | Naked mRNA | i.v. | Atezolizumab | Study ongoing |
| Solid tumors | NCT03313778 | Phase I | LNP | i.d. | Pembrolizumab | Study ongoing |
| Solid tumors | NCT03480152 | Phase I/II | Naked mRNA | i.m. | NA | MTD not reached |
| Solid tumors, lymphoma | NCT03468244 | NN | Naked mRNA | s.c. | NA | Study ongoing |
| Metastatic melanoma | NCT03815058 | Phase II | LNP | i.v. | Pembrolizumab | Study ongoing |
| High-risk of recurrence melanoma | NCT03897881 | Phase II | NN | NN | Pembrolizumab | Study ongoing |
| Esophageal cancer, NSCLC | NCT03908671 | NN | LNP | s.c. | NA | Study ongoing |
| Pancreas cancer | NCT04161755 | Phase I | NN | NN | Atezolizumab, chemotherapy | Study Ongoing |
| NSCLC | NCT04267237 | Phase I | LNP | i.v. | Atezolizumab | Study ongoing |
| KRAS-mutant pancreas, colon and lung cancer | NCT03948673 | Phase I | NN | i.m. | Pembrolizumab | Study ongoing |