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

NCT05226468 | Unknown Phase 1 DMC

• 1 other identifier: NEI01-20001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• Part1: MTD / RDL

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

  12 months

• Part1: Occurrence of DLT

  Occurrence of DLT (Dose Limiting Toxicity)

  Day 1 of single dosing till pre-dose assessment of Day 50

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

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

  From start of study until 28 days after last dose

• 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: From start of study until 28 days after last dose

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

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

  From start of study until 28 days after last dose

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

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

  From start of study until 28 days after last dose

• Part 2: DCR

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

  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)

• Part 1: Pharmacokinetics Profile - AUC 0-t

  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

• Part 1: Pharmacokinetics Profile - AUC 0-infinity

  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

• Part 1: Pharmacokinetics Profile - Cmax

  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

• Part 1: Pharmacokinetics Profile - Ctrough

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

• Part 1: Pharmacokinetics Profile - Cpeak

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

Study Arms (1)

NEI-01

EXPERIMENTAL

Single Arm

Drug: NEI-01

Interventions

NEI-01 DRUG

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

NEI-01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• New Epsilon Innovation Limited: lead

Study Sites (1)

The University of Hong Kong Phase I Clinical Trials Centre

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Christine Kwok, PhD

  New Epsilon Innovation Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 7, 2022
• Study Start: April 25, 2022
• Primary Completion: January 31, 2024
• Study Completion: July 31, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

HK (1)