Table 1.
Demographic details
| Module 1A—dose escalation N = 33 |
Module 1A—paired biopsy N = 11 |
Module 1B-1 N = 23 |
Module 2A N = 31 |
|
|---|---|---|---|---|
| Demographic details | ||||
| Age, years (range) | 59.6 (19−78) | 56.5 (26−75) | 53.6 (32–75) | 60.4 (41−81) |
| Sex, male/female (n, %) | 12 (36.4)/21 (63.6) | 0/11 (100.0) | 0/23 (100.0) | 0/31 (100.0) |
| Race, n (%) | ||||
| White | 28 (84.8) | 11 (100.0) | 19 (82.6) | 26 (83.9) |
| Black | 0 | 0 | 0 | 2 (6.5) |
| Asian | 3 (9.1) | 0 | 0 | 2 (6.5) |
| Other | 2 (6.1) | 0 | 4 (17.4) | 1 (3.2) |
| Cancer type | ||||
| Breast | 10 (30.3) | 11 (100.0) | 23 (100) | 31 (100.0) |
| Colorectal | 8 (24.2) | 0 | 0 | 0 |
| Liver | 1 (3.0) | 0 | 0 | 0 |
| Lung | 2 (6.1) | 0 | 0 | 0 |
| Pancreas | 1 (3.0) | 0 | 0 | 0 |
| Prostate | 2 (6.1) | 0 | 0 | 0 |
| Stomach | 1 (3.0) | 0 | 0 | 0 |
| Other | 8 (24.2) | 0 | 0 | 0 |
| Metastases, n (%) | 27 (81.8) | 9 (81.8) | 21 (91.3) | 31 (100.0) |
| Prior therapies, n (%) | ||||
| Chemotherapy | 29 (87.9) | 11 (100.0) | 23 (100.0) | 16 (51.6%) |
| Radiotherapy | 10 (30.3) | 8 (72.7) | 21 (91.3) | 21 (67.7) |
| Immunotherapy | 1 (3.0) | 0 | N/A | 3 (9.7) |
| Hormone therapy | 12 (36.4) | 10 (90.9) | 7 (30.4) | 31 (100.0) |
| CDK4/6 inhibitor therapy | 1 (3.0) | 0 | N/A | 31 (100.0) |
| Surgery | 3 (9.1) | 5 (45.5) | 23 (100.0) | 25 (80.6) |
| Other | 19 (57.6) | 8 (72.7) | N/A | 0 |
| Biological/immunological/other | N/A | N/A | 8 (34.8) | N/A |
N/A not applicable.