Table 1:
Demographics from First Visit
| Study | Total subjects (Number of concentrations) | Dose (mg/kg)* | Disease (N) | Age (years)* | Gender | Weight (kg)* | SCR* (mg/dL) | ALT* (U/L) | Total bilirubin* (mg/dL) | Albumin* (g/dL) |
|---|---|---|---|---|---|---|---|---|---|---|
| T01 | 66 (1400) | 5.4 (0.15 – 12.0) | 6 (66) | 59 (26 – 82) | Male: 52 Female: 14 |
83 (42 – 132) | 1.2 (0.8 – 2.1) | 18 (8 – 96) | 0.6 (0.2 – 1.8) | 4.1 (3.1 – 4.0) |
| T03 | 50 (1230) | 11.8 (2.9 – 13.6) | 2 (30) 4 (12) 5 (8) |
54 (18 – 82) | Male:0 Female: 50 |
78 (40 – 170) | 1.0 (0.5 – 2.4) | 18 (6 – 75) | 0.4 (0.2 – 1.8) | 3.8 (1.6 – 3.1) |
| MCD 2001 | 52 (929) | 11.0 (11.0 – 11.3) | 2 (52) | 47 (20 – 74) | Male: 32 Female: 20 |
67 (42 – 136) | 0.8 (0.5 – 1.7) | 15 (4 – 84) | 0.4 (0.2 – 1.7) | 3.6 (1.5 – 4.9) |
| SMM 1001 | 25 (204) | 15 (14.8 – 15.1) | 3 (11) 5 (14) |
58 (24 – 79) | Male: 9 Female: 16 |
69 (52 – 127) | 0.9 (0.5 – 1.9) | 20 (10 – 57) | 0.5 (0.2 – 1.0) | 3.9 (2.7 – 4.8) |
| SMM 2001 | 43 (352) | 15 (14.4 – 15.3) | 3 (43) | 61 (46 – 84) | Male: 26 Female: 17 |
78 (47 – 127) | 0.9 (0.5 – 1.6) | 19 (5 – 66) | 0.5 (0.2 – 1.8) | 3.7 2.7 – 4.7) |
| STM 2001 | 83 (791) | 15 (2.8 – 15.6) | 4 (83) | 60 (32 – 81) | Male: 29 Female: 54 |
69 (40 – 117) | 0.8 (0.4 – 1.9) | 23 (5 – 77) | 0.5 (0.1 – 1.8) | 3.8 (2.1 – 5) |
| T08 | 141 (2855) | 1.4 (0.2 – 2.8) | 1 (141) | 26 (19 – 45) | Male: 92 Female: 49 |
69 (51 – 92) | 0.8 (0.4 – 1.3) | 18 (9 – 73) | 0.7 (0.3 – 2.5) | 4.5 (3.8 – 5.2) |
| Overall | 460 (7761) | 9.2 (0.15 – 15.6) | 1 (141) 2 (82) 3 (54) 4 (95) 5 (22) 6 (66) |
51 (18 – 84) | Male: 240 Female: 220 |
73 (40 – 170) | 0.9 (0.4 – 2.4) | 19 (4 – 96) | 0.5 (0.1 – 2.5) | 4.1 (1.5 – 5.2) |
*
Data represent median (25-75% interquartile range)
Abbreviations: Disease: 1: Healthy volunteers; 2: Castleman’s disease; 3: smoldering multiple myeloma, 4: KRAS mutated/ovarian cancer/other solid tumors; 5: multiple myeloma/MGUS; 6: renal cell carcinoma