Study design
toxicities, treatment-emergent adverse, DLTs, tumor
TUMOR
A standard “3 + 3” dose-escalation design was used. The primary endpoints were incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs), determination of the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and characterization of the OBI-3424 pharmacokinetic profile. Secondary endpoints were tumor response as assessed by RECIST v1.1, and AKR1C3 expression in available tumor samples.