Table II.
Dose Level | Dose (mg/kg) | Number of Grade 3-4 AEs | ||
---|---|---|---|---|
IV Arm | SQ Arm | Cross-Over Arm | ||
1 | 0.15 | 0 | 1a | - |
2 | 0.45 | 0 | 2b | - |
3 | 0.75 | 0 | 4c | - |
4 | IV 1.05 (×1) | - | - | 1d |
SQ 0.45 (× 4-8) |
Grade 4 neutropenia
One grade 3 cancer-related pain, one grade 3 SGPT (ALT)
Two grade 3 myalgia, one grade 3 fatigue, one grade 3 constitutional symptom
Grade 3 headache