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Advanced Solid TumorPhase 1NCT05226468

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

A Phase 1 study testing NEI-01 in people with Advanced Solid Tumor and Relapsed AML, run by New Epsilon Innovation Limited at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Relapsed AML, Refractory AML
What is being tested?
NEI-01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteHong Kong
Study dates
25 Apr 2022to 31 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject must be capable of giving written informed consent.
  • Confirmed diagnosis of advanced solid tumor or relapsed/refractory AML as detailed below:
  • For Part 1 and 2 (Cohort 1): Histologically or cytologically confirmed diagnosis of any locally advanced or metastatic solid tumor
  • For Part 2 (Cohort 2): Histologically or cytologically confirmed diagnosis of relapsed or refractory AML as defined by World Health Organisation (WHO) classification
  • Existence of all of the following medical conditions or diagnoses:
  • For Solid Tumor Population:
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  • At least one measurable target lesion at screening, as defined by RECIST 1.1;
  • Life expectancy ≥ 12 weeks at screening;
  • ECOG performance status of 0 or 1 at screening;
  • Adequate bone marrow function at screening, as defined by: Hb ≥ 8 g/dL; ANC ≥ 1.5 × 109/L; AND Platelet count ≥ 75× 109/L;
  • Adequate coagulation function at screening, as defined by: PT or INR ≤ 1.5 × ULN; AND aPTT ≤ 1.5 × ULN;
  • Adequate liver function at screening, as defined by: Total bilirubin ≤ 1.5 × ULN; AND AST and ALT ≤ 2.5 × ULN OR ≤ 5 × ULN;
  • 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:
  • Life expectancy ≥ 12 weeks at screening;
  • ECOG performance status ≤ 2 at screening;
  • Adequate liver function at screening, as defined by: Total bilirubin ≤ 1.5× ULN; AND AST and ALT ≤ 3 ULN;
  • Adequate renal function at screening, as defined by: Creatinine ≤ 1.5 × ULN; OR Creatinine clearance ≥ 30 mL/min (by the Cockcroft Gault method).
  • Willingness and agreement to undertake measures to avoid pregnancy of the subject or the subject's sexual partner(s)
  • A female subject must be willing and agree to avoid engagement in breastfeeding.
  • Willingness and agreement to avoid blood donation.

Who cannot join

  • History of any of the following diseases or conditions:
  • Previous or concurrent active cancer that is distinct in primary site or histology from the cancer being evaluated in this study;
  • 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;
  • Any history of or current active cardiac disease or dysfunction;
  • Known history of HIV infection;
  • Known history of active HBV infection;
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  • Known history of active HCV infection.
  • Existence of any of the following medical conditions or diagnoses:
  • Positive pregnancy test;
  • Active infection requiring treatment by systemic therapy;
  • 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.
  • Use of any of the following prior or concomitant medications, therapies or interventions:
  • Prior treatment with ADI-PEG-20 or another experimental arginine deprivation strategy;
  • 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;
  • Any surgery within 28 days prior to the first dose of the study intervention.
  • Prior or concurrent participation in any other clinical study
  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong Phase I Clinical Trials Centre

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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

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.

Being tested
NEI-01
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEI-01Drug

    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

Study groups in NCT05226468
Study groupRoleWhat they receive
NEI-01ExperimentalSingle Arm
Receives: Drug: NEI-01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part1: MTD / RDL

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

    Measured: 12 months

  2. Part1: Occurrence of DLT

    Occurrence of DLT (Dose Limiting Toxicity)

    Measured: 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）

    Measured: 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）

    Measured: 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）

    Measured: 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）

    Measured: 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

    Measured: 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 (7)

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

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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start25 Apr 2022
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
3+3 design for dose escalation in Part 1 and Simon's optimal two stage design for dose expansion in Part 2. NEI-01 as single agent in both Part 1 and Part 2.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05226468
Sponsor's protocol ID
NEI01-20001
Status last verified
Jul 2023
First submitted
27 Jan 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NEI-01 in people with Advanced Solid Tumor and Relapsed AML, run by New Epsilon Innovation Limited at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part1: MTD / RDL (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05226468.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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