SLV-154 Treatment of Advanced Cancers

A Bayesian optimal interval (BOIN) design with a target dose-limiting toxicity (DLT) rate for the maximum tolerated dose (MTD) of 27% and an estimated maximum sample size of \~70 subjects will be used to guide the dose escalation and determine the recommended dosing regimen (RDR) of SLV-154. Once the initial RDR is established in the Phase 1a portion of this study, further development in the Phase 1b expansion portion of this study will be considered in patients with specific cancers. In the Phase 1b part of this study, enrollment of each tumor-specific cohort will be performed using a Simon 2-stage optimal design. SLV-154 will be administered intravenously (IV) in repeated 3-week cycles. Treatment will continue until progressive disease or discontinuation.