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

NCT05226468 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor
  • Relapsed AML
  • Refractory AML

Interventions

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

Sponsors & Collaborators

  • New Epsilon Innovation Limited

    lead INDUSTRY

Principal Investigators

  • Christine Kwok, PhD · New Epsilon Innovation Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2024-01-31
Completion
2024-07-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226468 on ClinicalTrials.gov