Table 3. Adverse Event1 Summary.
| Phase 1 Dose Levels | Combined Phase | |||||||
|---|---|---|---|---|---|---|---|---|
| 1 (N=6) | 2 (N=3) | 3 (N=6) | 4 (N=3) | 5 (N=3) | 62 (N=6) | Phase 1 (N=27) | Phase II RP2D3,4 (N=27) | |
| DLT (%) | 1 (16.7%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (16.7%) | 2 (7.4%) | 1 (3.7%) |
| Grade 3+ Overall | 5 (83.3%) | 3 (100.0%) | 4 (66.7%) | 2 (66.7%) | 2 (66.7%) | 4 (66.7%) | 20 (74.1%) | 22 (81.5%) |
| Grade 4+ Overall | 4 (66.7%) | 2 (66.7%) | 1 (16.7%) | 1 (33.3%) | 0 (0.0%) | 3 (50.0%) | 11 (40.7%) | 15 (55.6%) |
| Grade 3+ Heme | 3 (50.0%) | 1 (33.3%) | 2 (33.3%) | 2 (66.7%) | 2 (66.7%) | 4 (66.7%) | 14 (51.9%) | 22 (81.5%) |
| Grade 4 Heme | 2 (33.3%) | 0 (0.0%) | 1 (16.7%) | 0 (0.0%) | 0 (0.0%) | 3 (50.0%) | 6 (22.2%) | 15 (55.6%) |
| Grade 3+ Non-Heme | 4 (66.7%) | 3 (100.0%) | 4 (66.7%) | 1 (33.3%) | 1 (33.3%) | 3 (50.0%) | 16 (59.3%) | 12 (44.4%) |
| Grade 4+ Non-Heme | 2 (33.3%) | 2 (66.7%) | 0 (0.0%) | 1 (33.3%) | 0 (0.0%) | 0 (0.0%) | 5 (18.5%) | 2 (7.4%) |
1
Adverse events reported regardless of attribution
2
Included in phase II analysis
3
The recommended phase II dose (RP2D) included 6 phase I patients enrolled at dose level 6 and 21 patients enrolled during the phase II portion only.
4
One grade 5 pneumonitis possibly related to treatment occurred.