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

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.