Dose | 0.5 mg/kg QW | 1.0 mg/kg QW | 2.0 mg/kg QW | 4.0 mg/kg QW | 6.0 mg/kg QW | 6.0 mg/kg Q2W | 8.0 mg/kg Q2W | 9.0 mg/kg QW | 12.0 mg/kg QW | 15.0 mg/kg QW | Overall |
---|---|---|---|---|---|---|---|---|---|---|---|
(N=3) | (N=3) | (N=3) | (N=4) | (n=28) | (n=3) | (n=3) | (n=3) | (n=3) | (n=3) | (n=56) | |
Efficacy, n | |||||||||||
CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
PR | 0 | 0 | 0 | 0 | 12 | 2 | 0 | 0 | 2 | 1 | 17 |
SD | 0 | 0 | 1 | 2 | 12 | 1 | 2 | 2 | 1 | 1 | 22 |
PD | 3 | 2 | 2 | 2 | 3 | 0 | 1 | 1 | 0 | 1 | 15 |
NE | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 |
ORR (CR/PR), % (95% CI) | 0 (0.0–70.8) | 0 (0.0–70.8) | 0 (0.0–70.8) | 0 (0.0–60.2) | 42.9 (24.5–62.8) | 66.7 (9.4–99.2) | 0.0 (0.0–70.8) | 0.0 (0.0–70.8) | 66.7 (9.4–99.2) | 33.3 (0.8–90.6) | 30.4 (18.8–44.1) |
DCR (CR/PR/SD), % (95% CI) | 0 (0.0–70.8) | 0 (0.0–70.8) | 33.3 (0.8–90.6) | 50 (6.8– 93.2) | 85.7 (67.3–96.0) | 100.0 (29.2–100.0) | 66.7 (9.4–99.2) | 66.7 (9.4–99.2) | 100.0 (29.2–100.0) | 66.7 (9.4–99.2) | 69.6 (55.9–81.2) |