Demographics and baseline characteristics (Phase 1 and 2)
| Parameter, n (%) | Category/statistic | Phase 1 (N = 19) | Phase 2 (30 mcg/kg; N = 33) | |
|---|---|---|---|---|
| Gender, n (%) | Male | 15 (79) | 26 (79) | |
| Female | 4 (21) | 7 (21) | ||
| Age in years, Median (range) | 63 (48–77) | 61 (46–75) | ||
| ECOG, n (%) | 0 | 15 (79) | 15 (45) | |
| 1 | 4 (21) | 18 (55) | ||
| Prognostic risk category*, n (%) | Low risk | 12 (63) | 17 (52) | |
| Intermediate risk | 7 (37) | 16 (48) | ||
| Prior systemic treatment regimens for mRCC**, n (%) | 0 | 10 (53) | - | |
| 1 | 8 (42) | 25 (76) | ||
| 2 | 0 (0) | 8 (24) | ||
| 3 | 1 (5) | |||
| Agents used for prior systemic therapy**, n (%) | VEGFR-TKIs | |||
| Sunitinib | 4 (21) | 19 (58) | ||
| Pazopanib | 1 (3) | |||
| Cediranib | 1 (3) | |||
| mTOR Inhibitors | ||||
| Temsirolimus | 5 (15) | |||
| Everolimus | 2 (6) | |||
| Bevacizumab | 3 (9) | |||
| Immunotherapy | ||||
| IL-2 | 4 (21) | 11 (33) | ||
| Interferon | 1 (3) | |||
| Vaccine | 3 (9) | |||
| TLR-9 agonist | 1 (5) | |||
| IL-2 gene therapy | 1 (5) | |||
| Other | ||||
| Vinblastine | 1 (3) | |||
| ABT-510 | 1 (5) | |||
*Based on Memorial Sloan Kettering Cancer Center (MSKCC) risk categorization.
**Number of prior treatment regimens, could consist of a combination of agents.