Table 2.
Baseline characteristics – All treated population
| (N = 9) | Dose Escalation Bis Part with Loading Dose followed by 100 mg/m2 Q2 W (N = 16) |
Dose Escalation Q3 W Part (N = 9) |
|||||
|---|---|---|---|---|---|---|---|
| 80 mg/m2 Q2 W (n = 3) |
100 mg/m2 Q2 W (n = 6) |
135 mg/m2C1D1, then 100 mg/m2 Q2 W (n = 3) |
150 mg/m2 C1D1, then 100 mg/m2 Q2 W (n = 7) |
170 mg/m2 C1D1, then 100 mg/m2 Q2 W (n = 6) |
150 mg/m2 Q3 W (n = 3) |
170 mg/m2 Q3 W (n = 6) |
|
| Age (years) | |||||||
| Median | 66.0 | 69.0 | 50.0 | 55.0 | 59.0 | 57.0 | 69.0 |
| (min; max) | (41; 70) | (53; 72) | (49; 59) | (48; 74) | (51; 72) | (51; 68) | (57; 74) |
| Age, n (%) | |||||||
| < 65 | 1 (33.3) | 1 (16.7) | 3 (100) | 4 (57.1) | 4 (66.7) | 2 (66.7) | 1 (16.7) |
| 65–75 | 2 (66.7) | 5 (83.3) | 0 | 3 (42.9) | 2 (33.3) | 1 (33.3) | 5 (83.3) |
| ≥ 75 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gender, n (%) | |||||||
| Male | 0 | 4 (66.7) | 3 (100) | 3 (42.9) | 4 (66.7) | 1 (33.3) | 5 (83.3) |
| Female | 3 (100) | 2 (33.3) | 0 | 4 (57.1) | 2 (33.3) | 2 (66.7) | 1 (16.7) |
| Race, n (%) | |||||||
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 3 (100) | 6 (100) | 3 (100) | 7 (100) | 6 (100) | 3 (100) | 6 (100) |
| Black/African or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White/Caucasian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity, n (%) | |||||||
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 (100) | 6 (100) | 3 (100) | 7 (100) | 6 (100) | 3 (100) | 6 (100) |
| Unknown | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| ECOG PS | |||||||
| 0 | 2 (66.7) | 6 (100) | 3 (100) | 3 (42.9) | 5 (83.3) | 2 (66.7) | 5 (83.3) |
| 1 | 1 (33.3) | 0 | 0 | 4 (57.1) | 1 (16.7) | 1 (33.3) | 1 (16.7) |
| Body weight, kg | |||||||
| Median | 53.2 | 68.4 | 61.0 | 53.5 | 63.3 | 56.4 | 64.8 |
| (min; max) | (51.5; 56.1) | (54.8; 90.2) | (60.0; 73.0) | (43.2; 69.2) | (47.0; 68.2) | (40.5; 72.2) | (52.8; 80.9) |
| BSA (m2) | |||||||
| Median | 1.54 | 1.75 | 1.76 | 1.54 | 1.69 | 1.54 | 1.78 |
| (min; max) | (1.5; 1.6) | (1.5; 2.0) | (1.6; 1.8) | (1.4; 1.8) | (1.4; 1.8) | (1.4; 1.9) | (1.4; 1.9) |
| Prior regimens | |||||||
| Median | 7.0 | 4.0 | 5.0 | 6.0 | 5.5 | 4.0 | 5.0 |
| (min; max) | (5; 11) | (3; 8) | (4; 6) | (4; 9) | (4; 7) | (1; 8) | (3; 7) |
| Staging at initial diagnosis | 0 | 0 | |||||
| I | 0 | 0 | 1 (33.3) | 0 | 1 (16.7) | 0 | 0 |
| II | 0 | 0 | 0 | 1 (14.3) | 3 (50.0) | 1 (33.3) | 1 (16.7) |
| III | 1 (33.3) | 2 (33.3) | 2 (66.7) | 3 (42.9) | 1 (16.7) | 0 | 1 (16.7) |
| IV | 2 (66.7) | 4 (66.7) | 0 | 3 (42.9) | 1 (16.7) | 2 (66.7) | 4 (66.7) |
| Unknown | 0 | 0 | 0 | 0 | 0 | ||
| Duration of IMP exposure (weeks) | |||||||
| Median | 14 | 11 | 8.86 | 8.00 | 8.29 | 6.43 | 9.43 |
| (min; max) | (4; 16.1) | (8.1; 16.1) | (8.1; 28.1) | (2; 17.1) | (2; 29) | (6.3; 10.6) | (6; 21.3) |
| Primary tumor location, n (%) | |||||||
| Cecum | 1 (33.3) | 1 (16.7) | 0 | 1 (14.3) | 0 | ||
| Colon | 0 | 2 (33.3) | 0 | 2 (28.6) | 2 (33.3) | 1 (33.3) | 2 (33.3) |
| Gastroesophegal junction | 0 | 0 | 1 (33.3) | 0 | 0 | ||
| Pancreas | 0 | 0 | 0 | 1 (14.3) | 0 | 1 (33.3) | |
| Rectum | 2 (66.7) | 3 (50.0) | 2 (66.7) | 3 (42.9) | 4 (66.7) | 1 (33.3) | 3 (50.0) |
| Liver | 0 | 0 | 0 | 0 | 0 | 0 | |
| Extent at study entry, n (%) | 2 (66.7) | 5 (83.3) | |||||
| Metastatic* | 3 (100) | 5 (83.3) | 3 (100) | 5 (71.4) | 6 (100) | 1 (33.3) | 1 (16.7) |
| Locally advanced | 0 | 1 (16.7) | 0 | 2 (28.6) | 0 | ||
BSA body surface area; C cycle; D day; ECOG PS Eastern cooperative oncology group performance status; IMP investigational medicinal product; Q2 W every two weeks; Q3 W every three weeks
*Sites included bone, liver, lung, lymph node, rectum, colon, gastroesophageal junction, peritoneum, pleura, cecum