NCT05226468

An Early Phase Study of NEI-01 in Patients With Solid Tumors or Acute Myeloid Leukemia

A 2-part, First-in-patient, Open-label, Dose-escalation and Expansion Cohort Study of NEI-01 as Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory Acute Myeloid Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: New Epsilon Innovation Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Solid Tumor
• Relapsed AML
• Refractory AML

Interventions

Type	Name	Description
DRUG	NEI-01	Part1: Single dose period: Intravenous single dose of NEI-01 with 4 ascending dose levels. Multiple dose period: Intravenous weekly dose of NEI-01 for 9 weeks with 4 ascending dose levels. Part2: Intravenous weekly dose of NEI-01 at the recommended dose obtained from Part 1

Timeline

• Start date: 2022-04-25
• Primary completion: 2024-01-31
• Completion: 2024-07-31
• First posted: 2022-02-07
• Last updated: 2023-07-27

Locations

1 site across 1 country: Hong Kong