Table 1.
Various clinical trials involving claudiximab (IMAB362)
| Study-completion date | NCT number | Phase | Number of patients | Design | Response rate | OS | Median FPS | Adverse events |
|---|---|---|---|---|---|---|---|---|
| – | NCT00909025 | I | 15 | Single-dose escalation safety study | – | – | – | – |
| PILOT-2014 | NCT01671774 | I | 20 | Multiple dose, immunomodulation IMAB362 + zoledronic acid + IL-2 | 11 patients had disease control | 40 weeks | 12.7 weeks | Nausea and vomiting |
| MONO-2013 | NCT01197885 | IIA | 54 | Single arm, repeated dose, monotherapy study | Response rate-10% Disease control rate-30% |
– | 14.5 weeks | Vomiting |
| FAST-2015 | NCT01630083 | IIB | 161 +85 | Randomized EOX vs claudiximab + EOX, extended with high-dose claudiximab + EOX | Objective response rate- 25 vs 39% | 8.4 vs 13.4 months | 4.8 vs 7.9 months | Vomiting, neutrope-nia, and anemia |