Table 1.
Selected ongoing trials addressing immunotherapy resistance in solid tumors.
| Category | Trial | Phase | Mechanism of Experimental Agent | Primary Malignancies | Primary Outcome(s) |
|---|---|---|---|---|---|
| Antigen Presentation | NCT04943679 | I/II | Pegylated interferon | Hepatocellular carcinoma | AE |
| NCT04609579 | I | STING agonist | Advanced solid tumors, lymphoma | MTD AE |
|
| NCT05139082 | I/II | CDK4/6 inhibitor | Gastrointestinal tumors | ORR | |
| Cytokine Signaling/Production | NCT05472506 | I | AhR antagonist | Head and neck squamous cell carcinoma | AE ORR DCR DOR |
| NCT04691817 | I/II | Anti-IL-6 | Non-small cell lung cancer | ORR | |
| NCT03631199 | III | Anti-IL-1β | Non-small cell lung cancer | DLT PFS OS |
|
| Costimulatory Signals | NCT05082610 | I | Anti-VISTA | Advanced or metastatic solid tumors | DLT MTD AE |
| NCT04137900 | I | Anti-BTLA | Advanced solid tumors, lymphoma | AE | |
| NCT04080804 | II | Anti-LAG-3 | Resectable head and neck cancers | AE | |
| Bispecific Antibodies | NCT05263180 | I | Anti-PD-L1×OX40 | Advanced or metastatic solid tumors | AE sAE MTD DLT |
| NCT05442996 | I | Anti-EGFRx4-1BB | Advanced or metastatic solid tumors | AE DLT MTD |
|
| NCT03809624 | II | Anti-PDL1×4-1BB | Advanced or metastatic solid tumors | AE MTD or RPTD |
|
| TAM Polarization | NCT04682431 | Ia/Ib | TREM-1 inhibitor | Advanced or metastatic solid tumors | AE DLT |
| NCT04691375 | Ia/Ib | TREM-2 inhibitor | Advanced or metastatic solid tumors | AE DLT |
|
| Tryptophan Metabolism | NCT03414229 | II | IDO1 inhibitor | Advanced or metastatic sarcoma | Best ORR |
| NCT03459222 | I/II | IDO1 inhibitor | Advanced or metastatic solid tumors | AE sAE DLT ORR DCR DOR |
|
| Fecal Microbiota Modification/Transplantation |
NCT05251389 | Ib/IIa | Fecal microbiota from immunotherapy responder | Advanced stage cutaneous melanoma | ORR |
AE = adverse events; DCR = disease control rate; DLT = dose-limiting toxicities; DOR = duration of response; MTD = maximum tolerated dose; PFS = progression free survival; ORR = objective response rate; OS = overall survival; RPTD = recommended phase 2 dose; sAE = serious adverse events.