Table 1.
n (%) | Eganelisib dose escalation (Part A) | Eganelisib dose expansion (Part D: 60 mg) (n=20) | ||||||
---|---|---|---|---|---|---|---|---|
| ||||||||
10–30 mg (n=12) | 40 mg (n=4) | 60 mg (n=3) | ||||||
| ||||||||
Any grade | G≥3 | Any grade | G≥3 | Any grade | G≥3b | Any grade | G≥3 | |
Any treatment-related TEAE | 6 (50) | - | 3 (75) | - | 2 (67) | 2 (67) | 14 (70) | 8 (40) |
AST increased | 1 (8) | - | 2 (50) | - | 1 (33) | 1 (33) | 9 (45) | 6 (30) |
ALT increased | 2 (50) | - | 1 (33) | 1 (33) | 8 (40) | 6 (30) | ||
Rashc | 1 (8) | - | 2 (50) | - | 8 (40) | 2 (10) | ||
Fatigue | 1 (8) | - | 1 (25) | - | 3 (15) | - | ||
Headache | 2 (17) | - | 1 (5) | - | ||||
Blood ALP increased | 1 (33) | - | 2 (10) | 2 (10) | ||||
Dyspnea | 2 (10) | 1 (5) | ||||||
Amylase increased | 1 (8) | - | 1 (5) | - | ||||
Lipase increased | 1 (8) | - | 1 (5) | - | ||||
WBC decreased | 1 (25) | - | 1 (5) | - | ||||
Blood bilirubin increased | 1 (5) | 1 (5) | ||||||
Hypercalcemia | 1 (33) | 1 (33) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ALP, alkaline phosphatase; DLT, dose-limiting toxicity; G≥3, grade 3 or higher; TEAE, treatment-emergent adverse event; WBC, white blood cell count.
All events were grade 3 except for grade 4 increases in ALT and bilirubin that both occurred in the same patient.
No grade ≥3 events occurred during the DLT observation period (first treatment cycle).
Includes preferred terms pruritis, rash, and rash maculopapular.