Table 1.
Baseline patient demographics
| Variable | Part A: Dose Escalation | Part B: Cohort Expansion | Total Part A and Part B | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 5 mg/kg (N = 5) |
Cohort 2 10 mg/kg (N = 3) |
Cohort 3 4.0 mg/kg (N = 6) |
Total Part A (N = 14) |
Cohort 1 Pancreatic (N = 8) |
Cohort 2 Esophageal (N = 7) |
Cohort 3 Gastric (N = 8) |
Cohort 4 Colorectal (N = 9) |
Cohort 5 Basket (N = 8) |
Total Part B (N = 40) |
(N = 54) | |
| Sex, n (%) | |||||||||||
| Females | 5 (100) | 3 (100) | 3 (50.0) | 11 (78.6) | 6 (75.0) | 0 | 3 (37.5) | 2 (22.2) | 5 (62.5) | 16 (40.0) | 27 (50.0) |
| Males | 0 | 0 | 3 (50.0) | 3 (21.4) | 2 (25.0) | 7 (100) | 5 (62.5) | 7 (77.8) | 3 (37.5) | 24 (60.0) | 27 (50.0) |
| Age, years | |||||||||||
| Mean | 51.0 | 57.7 | 64.5 | 58.2 | 63.8 | 57.4 | 64.9 | 52.9 | 60.6 | 59.8 | 59.4 |
| SD | 12.9 | 9.5 | 12.1 | 12.6 | 13.3 | 9.4 | 9.7 | 14.8 | 8.1 | 11.8 | 11.9 |
| Median | 54.0 | 61.0 | 67.0 | 58.5 | 70.0 | 61.0 | 63.5 | 54.0 | 60.5 | 61.0 | 61.0 |
| Min – Max | 38/69 | 47/65 | 45/76 | 38/76 | 47/77 | 42/68 | 52/78 | 21/68 | 48/74 | 21/78 | 21/78 |
| Race (%) | |||||||||||
| Asian | 0 | 0 | 1 (16.7) | 1 (7.1) | 3 (37.5) | 6 (85.7) | 7 (87.5) | 0 | 4 (50.0) | 20 (50.0) | 21 (38.9) |
| Black | 1 (20.0) | 1 (33.3) | 0 | 2 (14.3) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (3.7) |
| Caucasian | 3 (60.0) | 1 (33.3) | 5 (83.3) | 9 (64.3) | 5 (62.5) | 1 (14.3) | 1 (12.5) | 9 (100) | 4 (50.0) | 20 (50.0) | 29 (53.7) |
| Native American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown | 1 (20.0) | 1 (33.3) | 0 | 2 (14.3) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (3.7) |
| Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity, n (%) | |||||||||||
| Hispanic or Latino | 1 (20.0) | 0 | 1 (16.7) | 2 (14.3) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (3.7) |
| East Asian | 0 | 0 | 0 | 0 | 3 (37.5) | 6 (85.7) | 7 (87.5) | 0 | 3 (37.5) | 19 (47.5) | 19 (35.2) |
| Not reported | 2 (40.0) | 0 | 1 (16.7) | 3 (21.4) | 1 (12.5) | 0 | 0 | 0 | 1 (12.5) | 2 (5.0) | 5 (9.3) |
| Other | 2 (40.0) | 2 (66.7) | 3 (50.0) | 7 (50.0) | 4 (50.0) | 1 (14.3) | 1 (12.5) | 8 (88.9) | 3 (37.5) | 17 (42.5) | 24 (44.4) |
| Unknown | 0 | 1 (33.3) | 1 (16.7) | 2 (14.3) | 0 | 0 | 0 | 1 (11.1) | 1 (12.5) | 2 (5.0) | 4 (7.4) |
| ECOG performance status, n (%) | |||||||||||
| 0 | 0 | 0 | 1 (16.7) | 1 (7.1) | 1 (12.5) | 0 | 6 (75.0) | 3 (33.3) | 4 (50.0) | 14 (35.0) | 15 (27.8) |
| 1 | 5 (100) | 3 (100) | 5 (83.3) | 13 (92.9) | 7 (87.5) | 7 (100) | 2 (25.0) | 6 (66.7) | 4 (50.0) | 26 (65.0) | 39 (72.2) |
| Time since initial diagnosis (months) | |||||||||||
| n | 5 | 3 | 6 | 14 | 8 | 7 | 8 | 9 | 8 | 40 | 54 |
| Mean | 49.7 | 25.8 | 55.7 | 47.1 | 48.6 | 17.3 | 48.7 | 50.3 | 44.2 | 42.7 | 43.8 |
| SD | 38.7 | 13.7 | 46.7 | 38.4 | 74.8 | 9.8 | 101.2 | 28.1 | 36.3 | 58.3 | 53.6 |
| Median | 69.7 | 23.7 | 32.3 | 32.3 | 18.6 | 13.2 | 12.7 | 46.5 | 37.7 | 23.4 | 25.6 |
| TNM stage at diagnosis, n (%) | |||||||||||
| Stage 1 | 0 | 0 | 1 (16.7) | 1 (7.1) | 0 | 0 | 0 | 1 (11.1) | 0 | 1 (2.5) | 2 (3.7) |
| Stage 2 | 0 | 0 | 0 | 0 | 2 (25.0) | 1 (14.3) | 0 | 0 | 1 (12.5) | 4 (10.0) | 4 (7.4) |
| Stage 3 | 1 (20.0) | 0 | 0 | 1 (7.1) | 2 (25.0) | 1 (14.3) | 1 (12.5) | 2 (22.2) | 2 (25.0) | 8 (20.0) | 9 (16.7) |
| Stage 4 | 0 | 0 | 2 (33.3) | 2 (14.3) | 1 (12.5) | 5 (71.4) | 7 (87.5) | 5 (55.6) | 1 (12.5) | 19 (47.5) | 21 (38.9) |
| Others | 4 (80.0) | 0 | 1 (16.7) | 5 (35.7) | 0 | 0 | 0 | 0 | 1 (12.5) | 1 (2.5) | 6 (11.1) |
| Not reported | 1 (12.5) | 0 | 0 | 1 (11.1) | 1 (12.5) | 3 (7.5) | 3 (5.6) | ||||
| Not available | 3 (100) | 2 (33.3) | 5 (35.7) | 2 (25.0) | 0 | 0 | 0 | 2 (25.0) | 4 (10) | 9 (16.7) | |
| Presence of metastasis, n (%) | |||||||||||
| Yes | 4 (80.0) | 2 (66.7) | 6 (100) | 12 (85.7) | 3 (37.5) | 7 (100) | 7 (87.5) | 9 (100) | 6 (75.0) | 32 (80.0) | 44 (81.5) |
| No | 1 (20.0) | 1 (33.3) | 0 | 2 (14.3) | 5 (62.5) | 0 | 1 (12.5) | 0 | 2 (25.0) | 8 (20.0) | 10 (18.5) |
| Location of metastases, n (%) | |||||||||||
| Bone | 0 | 0 | 1 (16.7) | 1 (7.1) | 0 | 0 | 1 (12.5) | 1 (11.1) | 0 | 2 (5.0) | 3 (5.6) |
| Left kidney | 1 (20.0) | 0 | 0 | 1 (7.1) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.9) |
| Liver | 0 | 1 (33.3) | 4 (66.7) | 5 (35.7) | 1 (12.5) | 1 (14.3) | 2 (25.0) | 6 (66.7) | 2 (25.0) | 12 (30.0) | 17 (31.5) |
| Liver and lung | 0 | 0 | 2 (33.3) | 2 (14.3) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (3.7) |
| Liver and lymph nodes | 0 | 0 | 1 (16.7) | 1 (7.1) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.9) |
| Lung | 3 (60.0) | 1 (33.3) | 2 (33.3) | 6 (43.6) | 1 (12.5) | 2 (28.6) | 1 (12.5) | 4 (44.4) | 2 (25.0) | 10 (25.0) | 16 (29.6) |
| Lymph nodes | 0 | 1 (33.3) | 1 (16.7) | 2 (14.3) | 3 (37.5) | 6 (87.5) | 5 (62.5) | 2 (22.2) | 4 (50.0) | 20 (50.0) | 22 (40.7) |
| Omentum /liver | 1 (20.0) | 0 | 0 | 1 (7.1) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.9) |
| Peritoneum | 0 | 0 | 0 | 0 | 1 (12.5) | 0 | 3 (37.5) | 1 (11.1) | 1 (12.5) | 6 (15.0) | 6 (11.1) |
| Other | 0 | 0 | 0 | 0 | 3 (37.5) | 1 (14.3) | 2 (25.0) | 4 (44.4) | 3 (37.5) | 13 (32.5) | 13 (24.1) |
| Globo H H-score, n | 8 | 7 | 8 | 9 | 8 | 40 | 40 | ||||
| Mean | 210.6 | 195.0 | 186.9 | 167.2 | 215.0 | 194.3 | 194.3 | ||||
| SD | 82.3 | 86.7 | 75.2 | 55.6 | 83.5 | 74.8 | 74.8 | ||||
| Median | 217.5 | 240.0 | 172.5 | 150.0 | 232.5 | 180.0 | 180.0 | ||||
| Min/Max | 100/300 | 100/300 | 100/300 | 100/285 | 100/300 | 100/300 | 100/300 | ||||
| Globo H H-score ≥ 100, n (%) | 8 (100) | 7 100) | 8 (100) | 9 (100) | 8 (100) | 40 (100) | 40 (74.1) | ||||