Table 1.
Baseline characteristics (safety analysis set)
| Characteristics | Dalutrafusp alfa doses (mg/kg) | |||||||
| 0.3 n=1 |
1 n=1 |
3 n=3 |
10 n=3 |
20 n=3 |
30 n=7 |
45 n=3 |
Total N=21 |
|
| Age, years, median (range) | 58 | 67 | 72 (60–77) | 64 (62–83) | 59 (56–70) | 55 (36–77) | 67 (66–79) | 65 (36–83) |
| Sex, female, n (%) | 0 | 1 | 3 | 2 | 2 | 6 | 1 | 15 (71.4) |
| Race, n (%) | ||||||||
| Black | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 3 (14.3) |
| White | 1 | 1 | 3 | 3 | 2 | 5 | 3 | 18 (85.7) |
| BMI, kg/m2, median (range) | 26.0 | 22.7 | 28.7 (22.0–34.7) | 20.3 (19.9–21.8) | 40.4 (32.1–40.8) | 33.6 (26.7–42.2) | 26.6 (26.3– 28.2) | 28.7 (19.9–42.2) |
| ECOG performance status, n (%) | ||||||||
| 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 2 (9.5) |
| 1 | 1 | 1 | 2 | 3 | 3 | 7 | 2 | 19 (90.5) |
| Number of prior anticancer regimens, median (range) | 4 | 3 | 4 (2–7) | 3 (3–3) | 7 (3–16) | 4 (1–8) | 6 (4–6) | 4 (1–16) |
| Malignancy type (best response) | ||||||||
| Colon | 1 (PD) | 0 | 0 | 0 | 0 | 1 (NA) | 2 (SD/PD) | 4 (19.0) |
| Bladder | 0 | 1 (NA) | 0 | 0 | 0 | 0 | 0 | 1 (4.8) |
| Renal cell | 0 | 0 | 1 (SD) | 0 | 0 | 0 | 0 | 2 (9.5) |
| NSCL | 0 | 0 | 1 (SD) | 0 | 1 (SD) | 0 | 0 | 1 (4.8) |
| Adrenal | 0 | 0 | 1 (PD) | 0 | 0 | 0 | 0 | 1 (4.8) |
| Pancreatic | 0 | 0 | 0 | 3 (PD/PD/PD) | 0 | 0 | 0 | 3 (14.3) |
| Appendiceal | 0 | 0 | 0 | 0 | 1 (PD) | 0 | 0 | 1 (4.8) |
| Ovarian | 0 | 0 | 0 | 0 | 1 (SD) | 1 (SD) | 1 (PD) | 3 (14.3) |
| Liposarcoma | 0 | 0 | 0 | 0 | 0 | 1 (SD) | 0 | 1 (4.8) |
| Endometrial | 0 | 0 | 0 | 0 | 0 | 2 (PD/PR) | 0 | 2 (9.5) |
| Rectal | 0 | 0 | 0 | 0 | 0 | 1 (NA) | 0 | 1 (4.8) |
| Breast | 0 | 0 | 0 | 0 | 0 | 1 (NA) | 0 | 1 (4.8) |
BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; NA, not available (patient did not make it to the first response); NSCL, non-small cell lung; PD, progressive disease; PR, partial response; SD, stable disease.