This is a single arm, single-center, open-label, ascending dose study in which dose escalation will be determined based on safety and tolerability. Up to a total of 6 cohorts of patients will be enrolled unless additional intermediate doses are studied, not to exceed the maximal dose per protocol.~There are 2 Parts to this study.~Part 1 involves enrolling sequential cohorts of patients into a dose-escalation design, in which doses are assessed for safety/tolerability.~Part 2 involves randomizing a cohort of patients to the highest and second-highest tolerated doses as identified in Part 1.
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and optimal recommended Phase 2 dose (RP2D) during a 28-day dosing period of ECP-1014 in patients with solid tumors and by evaluation of dose limiting toxicities.