Baseline characteristics in the dose-escalation and dose-expansion parts
| Dose-escalation part | Dose-expansion part | |||||
| Avelumab 10 mg/kg Q2W | Avelumab 800 mg QW→Q2W* plus M9241 16.8 µg/kg (n=7) | Avelumab 800 mg QW→Q2W* plus M9241 16.8 µg/kg (n=16) | ||||
| M9241 4 µg/kg (n=9) | M9241 8 µg/kg (n=7) | M9241 12 µg/kg (n=7) | M9241 16.8 µg/kg (n=6) | |||
| Median age, years (range) | 60 (41–68) | 64 (56–71) | 60 (46–75) | 55 (47–71) | 61 (56–74) | 66 (48–79) |
| Sex, n (%) | ||||||
| Male | 4 (44.4) | 5 (71.4) | 4 (57.1) | 4 (66.7) | 5 (71.4) | 12 (75.0) |
| Female | 5 (55.6) | 2 (28.6) | 3 (42.9) | 2 (33.3) | 2 (28.6) | 4 (25.0) |
| Race, n (%) | ||||||
| White | 7 (77.8) | 5 (71.4) | 6 (85.7) | 6 (100) | 6 (85.7) | 8 (50.0) |
| Black | 0 | 1 (14.3) | 1 (14.3) | 0 | 1 (14.3) | 0 |
| Asian | 1 (11.1) | 0 | 0 | 0 | 0 | 0 |
| Other | 1 (11.1) | 1 (14.3) | 0 | 0 | 0 | 0 |
| Not collected | 0 | 0 | 0 | 0 | 0 | 8 (50.0) |
| ECOG PS, n (%) | ||||||
| 0 | 3 (33.3) | 3 (42.9) | 3 (42.9) | 3 (50.0) | 3 (42.9) | 5 (31.3) |
| 1 | 6 (66.7) | 4 (57.1) | 4 (57.1) | 3 (50.0) | 4 (57.1) | 11 (68.8) |
| Prior lines of therapy for metastatic disease, n (%) | ||||||
| 1 | 0 | 1 (14.3) | 0 | 2 (33.3) | 4 (57.1) | 11 (68.8) |
| 2 | 1 (11.1) | 2 (28.6) | 2 (28.6) | 1 (16.7) | 0 | 2 (12.5) |
| 3 | 1 (11.1) | 1 (14.3) | 2 (28.6) | 0 | 1 (14.3) | 0 |
| ≥4 | 2 (22.2) | 2 (28.6) | 0 | 1 (16.7) | 1 (14.3) | 0 |
*Avelumab QW for 12 weeks then Q2W thereafter.
ECOG PS, Eastern Cooperative Oncology Group performance status; QW, once a week; Q2W, every 2 weeks.