Table 1 Baseline demographic and clinical characteristics.
Part 1 phase 1a N = 21 | Part 1 phase 1b nofazinlimab monotherapy | Part 2a nofazinlimab combination (nofazinlimab 300 mg Q4W) | |||||||
|---|---|---|---|---|---|---|---|---|---|
Arm 1 200 mg Q3W n = 20 | Arm 2 200 mg Q3W n = 7 | Arm 3 200 mg Q3W n = 29 | Arm 4 400 mg Q6W n = 31 | Total N = 87 | Regorafenib 80 mg n = 7 | Regorafenib 120 mg n = 7 | Total N = 14 | ||
Sex | |||||||||
Male | 13 (61.9) | 10 (50.0) | 4 (57.1) | 18 (62.1) | 22 (71.0) | 54 (62.1) | 4 (57.1) | 3 (42.9) | 7 (50.0) |
Female | 8 (38.1) | 10 (50.0) | 3 (42.9) | 11 (37.9) | 9 (29.0) | 33 (37.9) | 3 (42.9) | 4 (57.1) | 7 (50.0) |
Age, years | 63.0 (21, 83) | 57.0 (26, 85) | 70.0 (64, 76) | 64.0 (36, 84) | 68.0 (37, 83) | 65.0 (26, 85) | 56.0 (37, 70) | 44.0 (37, 64) | 49.0 (37, 70) |
Race | |||||||||
White | 19 (90.5) | 19 (95.0) | 7 (100.0) | 27 (93.1) | 27 (87.1) | 80 (92.0) | 5 (71.4) | 6 (85.7) | 11 (78.6) |
Asian | 2 (9.5) | 0 | 0 | 1 (3.4) | 4 (12.9) | 5 (5.7) | 1 (14.3) | 0 | 1 (7.1) |
Other | 0 | 1 (5.0) | 0 | 1 (3.4) | 0 | 2 (2.3) | 1 (14.3) | 1 (14.3) | 2 (14.3) |
ECOG PS | |||||||||
0 | 11 (52.4) | 14 (70.0) | 3 (42.9) | 14 (48.3) | 18 (58.1) | 49 (56.3) | 4 (57.1) | 5 (71.4) | 9 (64.3) |
1 | 10 (47.6) | 6 (30.0) | 4 (57.1) | 15 (51.7) | 13 (41.9) | 38 (43.7) | 3 (42.9) | 2 (28.6) | 5 (35.7) |
MSI-H/dMMR | |||||||||
Yes | 2 (9.5) | 1 (5.0) | 0 | 5 (17.2) | 5 (16.1) | 11 (12.6) | 0 | 0 | 0 |
No | 11 (52.4) | 2 (10.0) | 1 (14.3) | 7 (24.1) | 9 (29.0) | 19 (21.8) | 6 (85.7) | 4 (57.1) | 10 (71.4) |
Unknown | 8 (38.1) | 17 (85.0) | 6 (85.7) | 17 (58.6) | 17 (54.8) | 57 (65.5) | 1 (14.3) | 3 (42.9) | 4 (28.6) |
Patients with at least one KRAS/NRAS/BRAF mutation | — | — | — | — | — | — | 5 (71.4) | 2 (28.6) | 7 (50.0) |
KRAS mutation | — | — | — | — | — | — | 3 (42.9) | 2 (28.6) | 5 (35.7) |
NRAS mutation | — | — | — | — | — | — | 2 (28.6) | 0 | 2 (14.3) |
BRAF mutation | — | — | — | — | — | — | 0 | 1 (14.3) | 1 (7.1) |
Cancer stage at screening | |||||||||
Stage III | 0 | 0 | 6 (85.7) | 2 (6.9) | 3 (9.7) | 11 (12.6) | 0 | 0 | 0 |
Stage IV | 20 (95.2) | 20 (100.0) | 1 (14.3) | 25 (86.2) | 25 (80.6) | 71 (81.6) | 7 (100) | 7 (100) | 14 (100) |
Other | 1 (4.8) | 0 | 0 | 2 (6.9) | 3 (9.7) | 5 (5.7) | 0 | 0 | 0 |
Metastases | |||||||||
Yes | 20 (95.2) | 20 (100.0) | 1 (14.3) | 28 (96.6) | 28 (90.3) | 77 (88.5) | 7 (100.0) | 7 (100.0) | 14 (100.0) |
No | 1 (4.8) | 0 | 6 (85.7) | 1 (3.4) | 3 (9.7) | 10 (11.5) | 0 | 0 | 0 |
No. of prior systemic cancer therapy regimen | 1.0 (0, 9) | 2.0 (0, 4) | 1.0 (0, 2) | 1.0 (0, 9) | 1.0 (0, 5) | 1.0 (0, 9) | 4.0 (2, 6) | 4.0 (3, 7) | 4.0 (2, 7) |
