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Active, not recruitingNCT05226468Updated Jul 27, 2023

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

A Phase 1 interventional study of NEI-01 in Advanced Solid Tumor, Relapsed AML and Refractory AML, sponsored by New Epsilon Innovation Limited. Active, not recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by New Epsilon Innovation Limited · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 8 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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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.

Read the 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.

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Conditions studied

  • Advanced Solid Tumor
  • Relapsed AML
  • Refractory AML
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In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's planned enrollment of 24 is below the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

This is the only study on the registry with New Epsilon Innovation Limited as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The subject must be capable of giving written informed consent.

  2. Confirmed diagnosis of advanced solid tumor or relapsed/refractory AML as detailed below:

    1. For Part 1 and 2 (Cohort 1): Histologically or cytologically confirmed diagnosis of any locally advanced or metastatic solid tumor
    2. For Part 2 (Cohort 2): Histologically or cytologically confirmed diagnosis of relapsed or refractory AML as defined by World Health Organisation (WHO) classification

  3. Existence of all of the following medical conditions or diagnoses:

    For Solid Tumor Population:

    1. At least one measurable target lesion at screening, as defined by RECIST 1.1;
    2. Life expectancy ≥ 12 weeks at screening;
    3. ECOG performance status of 0 or 1 at screening;
    4. Adequate bone marrow function at screening, as defined by: Hb ≥ 8 g/dL; ANC ≥ 1.5 × 109/L; AND Platelet count ≥ 75× 109/L;
    5. Adequate coagulation function at screening, as defined by: PT or INR ≤ 1.5 × ULN; AND aPTT ≤ 1.5 × ULN;
    6. Adequate liver function at screening, as defined by: Total bilirubin ≤ 1.5 × ULN; AND AST and ALT ≤ 2.5 × ULN OR ≤ 5 × ULN;
    7. Adequate renal function at screening, as defined by: Creatinine ≤ 1.5 × ULN; OR Creatinine clearance ≥ 50 mL/min.

    For Part 2 (Cohort 2) - AML Population:

    1. Life expectancy ≥ 12 weeks at screening;
    2. ECOG performance status ≤ 2 at screening;
    3. Adequate liver function at screening, as defined by: Total bilirubin ≤ 1.5× ULN; AND AST and ALT ≤ 3 ULN;
    4. Adequate renal function at screening, as defined by: Creatinine ≤ 1.5 × ULN; OR Creatinine clearance ≥ 30 mL/min (by the Cockcroft Gault method).
  4. Willingness and agreement to undertake measures to avoid pregnancy of the subject or the subject's sexual partner(s)
  5. A female subject must be willing and agree to avoid engagement in breastfeeding.
  6. Willingness and agreement to avoid blood donation.

Exclusion criteria

Exclusion Criteria:

  1. History of any of the following diseases or conditions:

    1. Previous or concurrent active cancer that is distinct in primary site or histology from the cancer being evaluated in this study;
    2. Known CNS metastasis(es), unless the metastasis(es) was/were treated and became stable and the subject does not require systemic corticosteroids for management of CNS symptoms for at least 14 days prior to the first dose of study intervention;
    3. Any history of or current active cardiac disease or dysfunction;
    4. Known history of HIV infection;
    5. Known history of active HBV infection;
    6. Known history of active HCV infection.

  2. Existence of any of the following medical conditions or diagnoses:

    1. Positive pregnancy test;
    2. Active infection requiring treatment by systemic therapy;
    3. Any unresolved toxicity related to any prior therapy of ≥ Grade 2 (as defined by NCI CTCAE v5.0) prior to the first dose of the study intervention.

  3. Use of any of the following prior or concomitant medications, therapies or interventions:

    1. Prior treatment with ADI-PEG-20 or another experimental arginine deprivation strategy;
    2. Any anti-cancer therapy within 21 days prior to the first dose of the study intervention and/or during the subject's participation in the study;
    3. Any surgery within 28 days prior to the first dose of the study intervention.
  4. Prior or concurrent participation in any other clinical study
  5. Any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    NEI-01

    Single Arm

    Drug: NEI-01

Interventions

  • DrugNEI-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

06

What researchers measure

Primary outcomes

  1. Part1: MTD / RDL

    MTD (Maximum tolerable dose) / Recommended dose level (RDL)

    Time frame: 12 months

  2. Part1: Occurrence of DLT

    Occurrence of DLT (Dose Limiting Toxicity)

    Time frame: Day 1 of single dosing till pre-dose assessment of Day 50

  3. Part1: Occurrence of AE and SAE（NCI CTCAE 5.0）

    Occurrence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

    Time frame: From start of study until 28 days after last dose

  4. Part1: Frequency of AE and SAE（NCI CTCAE 5.0）

    Frequency of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

    Time frame: Time Frame: From start of study until 28 days after last dose

  5. Part2: Occurrence of AE and SAE（NCI CTCAE 5.0）

    Occurrence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

    Time frame: From start of study until 28 days after last dose

  6. Part2: Frequency of AE and SAE（NCI CTCAE 5.0）

    Frequency of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

    Time frame: From start of study until 28 days after last dose

  7. Part 2: DCR

    Disease Control Rate (DCR) Evaluate by RECIST 1.1 or 2003 IWG AML Response Criteria

    Time frame: From prior to first dose of study medication, within 2 days after Week 6 Day 1, then every 6 weeks until treatment discontinuation

Secondary outcomes

  1. Part 1: Pharmacokinetics Profile - AUC 0-t

    The area under the plasma drug concentration-time curve up to t = 504h (AUC0-t)

    Time frame: Single dose : Pre-dose, 0 hour, 0.25hour, 0.5hour, 0.75 hour, 1hour, 6hours, 12hours, 24hours, 48hours, 72 hours, 168 hours, 336 hours and 504 hours post-end of infusion of the initial dose

  2. Part 1: Pharmacokinetics Profile - AUC 0-infinity

    The area under the plasma drug concentration-time curve to infinite time (AUC0-infinity)

    Time frame: Single dose : Pre-dose, 0 hour, 0.25hour, 0.5hour, 0.75 hour, 1hour, 6hours, 12hours, 24hours, 48hours, 72 hours, 168 hours, 336 hours and 504 hours post-end of infusion of the initial dose

  3. Part 1: Pharmacokinetics Profile - Cmax

    The maximum plasma concentration (Cmax)

    Time frame: Single dose : Pre-dose, 0 hour, 0.25hour, 0.5hour, 0.75 hour, 1hour, 6hours, 12hours, 24hours, 48hours, 72 hours, 168 hours, 336 hours and 504 hours post-end of infusion of the initial dose

  4. Part 1: Pharmacokinetics Profile - Ctrough

    The trough level of observed plasma concentration (Ctrough)

    Time frame: Multiple dose: Pre-dose, 0.25hour post-end of infusion of Week 1 Day 1 (W1D1), W2D1, W3D1, W4D1 and W5D1

  5. Part 1: Pharmacokinetics Profile - Cpeak

    The peak level of observed plasma concentration (Cpeak)

    Time frame: Multiple dose: Pre-dose, 0.25hour post-end of infusion of Week 1 Day 1 (W1D1), W2D1, W3D1, W4D1 and W5D1

  6. Part 1: DCR

    Disease Control Rate (DCR) Evaluate by RECIST 1.1

    Time frame: From prior to first dose of study medication, within 2 days after Week 6 Day 1, then every 6 weeks until treatment discontinuation, an average of 9 months

  7. Part 2: ORR

    Objective Response Rate (ORR) Evaluate by RECIST 1.1 or 2003 IWG AML Response Criteria

    Time frame: From prior to first dose of study medication, within 2 days after Week 6 Day 1, then every 6 weeks until treatment discontinuation, an average of 9 months

07

Study locations

1 site
  • The University of Hong Kong Phase I Clinical Trials Centre
    Hong Kong, Hong Kong
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05226468
Lead sponsor
New Epsilon Innovation Limited
Responsible party
Sponsor
First posted
Feb 7, 2022
Start date
Apr 25, 2022
Primary completion
Jan 31, 2024 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Jul 27, 2023

Study contacts

Christine Kwok, PhD
study director · New Epsilon Innovation Limited

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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