First-in-Human, Dose Finding, Open Label Phase 1A-1B Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies

• Signed informed consent and mental capability to understand the informed consent

• Male or female patients \> 18 years of age

• Histologically or cytologically documented locally advanced or metastatic solid tumor malignancies either treatment-refractory or otherwise ineligible for treatment with standard-of-care agents/regimens

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

• Evaluable or measurable disease per RECIST v1.1

• Life expectancy \> 3 months

• ECG without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the Investigator

• Acceptable organ and marrow function as defined below:

‣ Absolute neutrophil count \> 1,500 cells/μL

⁃ Hemoglobin ≥ 9.0 g/dL

⁃ Platelets \> 100,000 cells/μL

⁃ Total bilirubin ≤ 1.5 mg/dL

⁃ Albumin ≥ 3 g/dL

⁃ Aspartate aminotransferase (AST)/alanine transaminase (ALT)/alkaline phosphatase (ALP)/Gamm-glutamyl transferase (GGT) ≤ 2.5 times ULN. For Phase 1A only, if liver metastases are present, AST/ALT/ALP \< 5 times ULN

⁃ Serum creatinine \< 1.5 mg./dL and a measured creatinine clearance ≥ 60 mL/min

⁃ Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 times ULN

• Women of child-bearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, e.g., greater than 45 years) must have a negative serum pregnancy test prior to first dose of study drug.

⁃ Male and female patients with reproductive potential must agree to use adequate contraceptive precautions throughout the study.