DLTs
sepsis, TEAEs, renal impairment, bleeding
SEPSIS, RENAL IMPAIRMENT, BLEEDING
In the dose de-escalation phase, only 1 patient of the first 6 patients required dose interruption between cycles 1 and 2, because of sepsis (considered unlikely related to the study drug) and renal impairment (considered possibly related to the study drug). One patient reported grade 3 platelet count decreased but had no active bleeding. Other 4 patients experienced grade 2 or less TEAEs within the first 28 days of treatment. In general, GT90001 7.0 mg/kg was well tolerated and no DLTs were observed in the 7.0 mg/kg cohort. Therefore, no dose de-escalation was required and GT90001 7.0 mg/kg was confirmed as the RP2D when combined with nivolumab.