Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours
Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
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.