Table 1.
Demographics and baseline characteristics
| Characteristic | Part A | Part B | Part C | Part D | ||
| DOS+NIR 200 mg (n=16) |
DOS+NIR 300 mg (n=6) |
DOS+C–P (n=14) |
DOS+NIR 200 mg +BEV (n=6) |
DOS+NIR 300 mg +BEV (n=7) |
DOS+C–P+BEV (n=6) |
|
| Age, years | ||||||
| Median (mean) | 63.5 (60.9) | 61.5 (60.5) | 70.5 (67.6) | 59.0 (57.0) | 46.0 (49.4) | 65.0 (66.8) |
| Range | 39–85 | 40–79 | 41–82 | 37–74 | 35–66 | 60–80 |
| Age group, years, n (%) | ||||||
| <65 | 8 (50.0) | 3 (50.0) | 5 (35.7) | 4 (66.7) | 6 (85.7) | 2 (33.3) |
| ≥65 | 8 (50.0) | 3 (50.0) | 9 (64.3) | 2 (33.3) | 1 (14.3) | 4 (66.7) |
| Body weight, kg | ||||||
| Mean | 82.0 | 96.6 | 81.6 | 85.1 | 88.6 | 80.5 |
| Range | 47.7–131.3 | 78.3–126.2 | 49.9–135.0 | 59.9–114.1 | 76.4–121.9 | 42.3–108.0 |
| Sex, n (%) | ||||||
| Female | 9 (56.3) | 2 (33.3) | 8 (57.1) | 4 (66.7) | 7 (100.0) | 5 (83.3) |
| Male | 7 (43.8) | 4 (66.7) | 6 (42.9) | 2 (33.3) | 0 | 1 (16.7) |
| ECOG performance status, n (%) | ||||||
| 0 | 8 (50.0) | 3 (50.0) | 8 (57.1) | 2 (33.3) | 4 (57.1) | 3 (50.0) |
| 1 | 8 (50.0) | 3 (50.0) | 6 (42.9) | 4 (66.7) | 3 (42.9) | 3 (50.0) |
| Prior regimens | ||||||
| Median (mean) | 2.0 (2.2) | 2.5 (2.3) | 1.0 (1.6) | 1.5 (2.7) | 2.0 (3.0) | 1.0 (1.3) |
| Primary tumor site at first diagnosis, n (%) | ||||||
| Bladder | 1 (6.3) | 0 | 1 (7.1) | 0 | 0 | 0 |
| Breast | 3 (18.8) | 0 | 2 (14.3) | 1 (16.7) | 2 (28.6) | 0 |
| Cholangiocarcinoma | 0 | 0 | 0 | 0 | 2 (28.6) | 1 (16.7) |
| Colorectal | 2 (12.5) | 4 (66.7) | 1 (7.1) | 0 | 0 | 0 |
| Endometrium | 1 (6.3) | 0 | 0 | 0 | 0 | 1 (16.7) |
| Gastric | 1 (6.3) | 0 | 1 (7.1) | 0 | 0 | 0 |
| Gastrointestinal stromal tumor | 2 (12.5) | 2 (33.3) | 0 | 1 (16.7) | 0 | 0 |
| Head and neck | 1 (6.3) | 0 | 2 (14.3) | 0 | 0 | 1 (16.7) |
| Liver | 1 (6.3) | 1 (16.7) | 0 | 0 | 0 | 0 |
| Lung, small cell | 0 | 0 | 3 (21.4) | 0 | 0 | 0 |
| NSCLC | 1 (6.3) | 0 | 1 (7.1) | 0 | 0 | 1 (16.7) |
| Ovarian | 1 (6.3) | 0 | 0 | 1 (16.7) | 1 (14.3) | 1 (16.7) |
| Pancreas | 1 (6.3) | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 |
| Prostate | 1 (6.3) | 1 (16.7) | 1 (7.1) | 1 (16.7) | 0 | 0 |
| Other* | 1 (6.3) | 0 | 2 (14.3) | 1 (16.7) | 2 (28.6) | 1 (16.7) |
*Other includes appendix, squamous cell carcinoma, vulva, leiomyosarcoma, fallopian tube, uterus, and esophageal cancers.
BEV, bevacizumab; C–P, carboplatin–paclitaxel; DOS, dostarlimab; ECOG, Eastern Cooperative Oncology Group; NIR, niraparib; NSCLC, non-small cell lung cancer.