Table 1.
Demographic and baseline disease characteristicsa (safety population).
| Nadunolimab dose | 1.0 mg/kg (N = 20) n (%) | 2.5 mg/kg (N = 20) n (%) | 5.0 mg/kg (N = 28) n (%) | 7.5 mg/kg (N = 8) n (%) | Total (N = 76) n (%) |
|---|---|---|---|---|---|
| Characteristic | |||||
| Age (years), mean (SD) | 61.5 (9.7) | 63.8 (9.5) | 64.5 (8.6) | 59.9 (12.5) | 63.0 (9.5) |
| Sex | |||||
| Male | 13 (65) | 12 (60) | 16 (57) | 3 (38) | 44 (58) |
| Female | 7 (35) | 8 (40) | 12 (43) | 5 (63) | 32 (42) |
| Stage IV at initial diagnosis | 14 (70) | 13 (65) | 26 (93) | 8 (100) | 61 (80) |
| Stage at study entry | |||||
| III | 1 (5) | 1 (5) | — | — | 2 (3) |
| IV | 19 (95) | 19 (95) | 28 (100) | 8 (100) | 74 (97) |
| Tumor localization at study entry | |||||
| Bone | — | — | 1 (4) | 1 (13) | 2 (3) |
| Liver | 10 (50) | 11 (55) | 22 (79) | 6 (75) | 49 (65) |
| Lung | 5 (25) | 5 (25) | 12 (43) | 2 (25) | 24 (32) |
| Lymph nodes | 12 (60) | 10 (50) | 14 (50) | 2 (25) | 38 (50) |
| Other | 6 (30) | 8 (40) | 11 (39) | 2 (25) | 27 (36) |
| Previous therapy | |||||
| Chemotherapy | 2 (10) | 2 (10) | 3 (11) | — | 7 (9) |
| Pancreaticoduodenectomy/pancreatectomy | 2 (10) | 3 (15) | 4 (14) | — | 9 (12) |
| CA 19-9 (U/mL), median, n (range)b | 1,666, n = 20 (1.0–79,200) | 137, n = 20 (1.2–105,000) | 461, n = 26 (1.9–100,234) | 712, n = 4 (8.6–4,490) | 550, n = 70 (1.0–105,000) |
| Biopsy available for assessment of biomarkers | 12 | 13 | 18 | 6 | 49 |
| IL1RAP high | 8 | 8 | 10 | 3 | 29 |
| IL1RAP low | 4 | 5 | 8 | 3 | 20 |
Abbreviation: mITT population, modified intention-to-treat population.
a
68 participants (89%) were White, 1 was Asian, and 7 were not reported.
b
CA 19-9 = reported for the mITT population.