This is a Phase 1, open-label, non-randomized, 2-part dose-escalation and cohort expansion study of NEI-01 monotherapy in patients with advanced solid tumors or relapsed/refractory acute myeloid leukemia (AML).~This study consists of 2 parts: Part 1) the dose-escalation part in patients with advanced solid tumors and Part 2) the cohort expansion part of the study of NEI-01 in patients with advanced solid tumors or relapsed/refractory AML.~The primary objective of Part 1 are to evaluate the safety and tolerability of NEI-01, identify the maximum tolerated dose (MTD), and define the RDL for Part 2 of the study. The pharmacokinetics (PK) profile and preliminary efficacy of NEI-01 will also be evaluated whereas Part 2 is to assess the safety, tolerability and efficacy at weekly doses of NEI-01 at the RDL in subjects with advanced solid tumors or relapsed/refractory AML.~Part 1: This part will be conducted in 4 dose ascending cohorts, including single dose and multiple dose periods. The DLT will be observed up to pre-dose assessment of Day 50. Dose escalation decision will be made based on safety data collected from all the subjects enrolled in the dose group will be evaluated by a Data and Safety Monitoring Committee (DSMC).~Part 2: This part will only include the recommended dose (RDL) defined in Part 1. NEI-01 will be administered as a single agent in patients with advanced solid tumors (Cohort 1) or relapsed/refractory AML (Cohort 2). It will start after the RDL has been defined in Part 1 of the study. All subjects will receive weekly doses of NEI-01 at the RDL.
This is an early phase clinical study using NEI-01 as single agent in oncology indication. This is an open label study and it's divided into two parts.~Part 1: This part is ascending dose design to determine the safety and tolerability of NEI-01 and find out recommended dose of NEI-01 in solid tumor patient.~Part 2: This part is extended dose design to determine the effectiveness of NEI-01 in in solid tumor and acute myeloid leukemia patients.