Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours

Summary

The main purpose of this study is to evaluate the safety and tolerability of EVT801 in subjects with advanced or metastatic solid tumours. The study also aims to determine the maximum tolerated dose (MTD) and / or a recommended Phase 2 dose (RP2D) of EVT801 when administered daily to subjects with advanced or metastatic solid tumours. The study comprises two stages, each with distinct purposes, patient populations, and procedures: * Stage 1: a multiple ascending dose escalation of EVT801 to evaluate the safety and tolerability of EVT801 and to determine MTD / RP2D in subjects with advanced solid tumours. * Stage 2: a biomarker expansion cohort, in which all subjects will receive EVT801 at the MTD / RP2D, to explore pharmacodynamic outcomes and further elucidate tolerability, activity, and pharmacokinetics.

Timeline

Start

2021-11-03

Primary completion

2024-11-04

Completion

2024-11-22

Drugs

Indications