Demographics and baseline clinical characteristics
| Demographic parameter | Dose escalation (Part 1; n = 39) | Dose expansion (Part 2; n = 71) | Overall (N = 110) |
|---|---|---|---|
| Median age, years (range) | 58.0 (19–81) | 57.0 (18–88) | 57.0 (18–88) |
| Male, n (%) | 6 (15.4) | 28 (39.4) | 34 (30.9) |
| ECOG performance status, n (%) | |||
| 0 | 23 (59.0) | 37 (52.1) | 60 (54.5) |
| 1 | 16 (41.0) | 34 (47.9) | 50 (45.5) |
| Tumor type, n (%) | |||
| Breast | 8 (20.5) | 12 (16.9) | 20 (18.2) |
| Ovarian/peritoneal | 23 (59.0) | 11 (15.5) | 34 (30.9) |
| Prostate | 1 (2.6) | 3 (4.2) | 4 (3.6) |
| Pancreatic | 3 (7.7) | 10 (14.1) | 13 (11.8) |
| Ewing sarcoma | 2 (5.1) | 12 (16.9) | 14 (12.7) |
| SCLC | 0 | 23 (32.4) | 23 (20.9) |
| Colorectal | 2 (5.1) | 0 | 2 (1.8) |
| Deleterious mutation, n (%) | |||
| gBRCA1 | 16 (41.0) | 13 (18.3) | 29 (26.4) |
| gBRCA2 | 7 (17.9) | 20 (28.2) | 27 (24.5) |
| gBRCA1/2 | 1 (2.6) | 2 (2.8) | 3 (2.7) |
| Median prior chemotherapy regimens, n (range) | 4.0 (1.0–13.0) | 2.0 (0.0–6.0) | 2.5 (0.0–13.0) |
| Median prior platinum regimens, n (range) | 2.0 (0.0–4.0) | 1.0 (0.0–4.0) | 1.0 (0.0–4.0) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; gBRCA, germline BRCA mutated.