Table 2.
Overview of AEs during dose escalation and treatment-related AEs at the recommended weekly uptitration regimen of 15/20 mg.
| AE, n (%) | AEs during dose escalation—FAP-IL2v once weekly dosing | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Flat dosing | Uptitration regimen | Expansion | Combined | |||||||
| Cohort 1: 5 mg (n = 3) | Cohort 2: 10 mg (n = 4) | Cohort 3: 20 mg (n = 4) | Cohort 4: 25 mg (n = 5) | Cohort 5: 20/20/35 mg (n = 5) | Cohort 6: 20/35/35 mg (n = 1) | Cohort 7: 20/25 mg (n = 5) | Cohort 8: 15/20 mg (n = 11) | Cohort 9: 15/20 mg (n = 23) | All part A participants (N = 61) | |
| Participants with ≥1 event, n (%) | ||||||||||
| AE | 3 (100) | 4 (100) | 4 (100) | 5 (100) | 5 (100) | 1 (100) | 5 (100) | 11 (100) | 23 (100) | 61 (100) |
| Treatment-related | 3 (100) | 3 (75) | 4 (100) | 5 (100) | 5 (100) | 1 (100) | 5 (100) | 11 (100) | 23 (100) | 60 (98) |
| SAE | 1 (33) | 1 (25) | 2 (50) | 4 (80) | 4 (80) | 1 (100) | 3 (60) | 9 (82) | 17 (74) | 42 (69) |
| Treatment-related | 1 (33) | 0 | 2 (50) | 2 (40) | 4 (80) | 1 (100) | 2 (40) | 9 (82) | 16 (70) | 37 (61) |
| AEs leading to dose modification/interruption | 1 (33) | 2 (50) | 1 (25) | 4 (80) | 5 (100) | 1 (100) | 3 (60) | 9 (82) | 16 (70) | 42 (69) |
| AEs leading to treatment withdrawal | 0 | 0 | 1 (25) | 0 | 0 | 1 (100) | 1 (20) | 2 (18) | 1 (4) | 6 (10) |
| Grade ≥3 AE | 2 (67) | 1 (25) | 2 (50) | 5 (100) | 5 (100) | 1 (100) | 4 (80) | 10 (91) | 23 (100) | 54 (89) |
| DLT | 0 | 0 | 1 (25) | 1 (20) | 0 | 1 (100) | 2 (40) | 0 | 0 | 5 (8) |
| Most common treatment-related AEs (≥20% of the participants) at the recommended weekly dose of 15/20 mg (n = 34) | ||
|---|---|---|
| AE, n (%) | All grades | Grade 3 or 4 |
| Pyrexia | 25 (74) | 5 (15) |
| IRR | 22 (65) | 7 (21) |
| Chills | 20 (59) | 0 |
| Fatigue | 15 (44) | 2 (6) |
| Nausea | 14 (41) | 0 |
| Asthenia | 14 (41) | 4 (12) |
| Decreased appetite | 10 (29) | 1 (3) |
| Peripheral edema | 9 (26) | 0 |
| Diarrhea | 8 (24) | 0 |
| Vomiting | 8 (24) | 0 |
| AST increased | 8 (24) | 2 (6) |
| ALT increased | 8 (24) | 2 (6) |
| Blood bilirubin increased | 8 (24) | 0 |
| Hypotension | 8 (24) | 2 (6) |
| Rash | 7 (21) | 2 (6) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate transaminase.