A First-in-Human, Multicenter, Open-label, Phase 1 Dose-Escalation Study of LZM009 in Subjects With Advanced Solid Tumors

• Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

• Histologically or cytologically confirmed solid malignancy.

• Male or non-pregnant, non-lactating female patients age ≥18 years.

• Locally advanced or metastatic disease that is refractory to standard therapy \[note for patients with NSCLC patients with activating ALK translocation or EGFR mutations must have been treated and failed appropriate therapy\], or for which there is no standard available therapy.

• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

• Subject with a life expectancy of ≥ 12 weeks.

• Adequate hematologic function as indicated by

∙ Platelet count ≥ 100,000/mm3

‣ Hemoglobin ≥ 9.0g/dL

‣ Absolute neutrophil count (ANC) ≥1000/uL Note: Use of growth-factors to maintain ANC criterion (within 28 days prior to the first dose of study drug and within 28 days after day 1 of Cycle 1) is not permitted.

• Adequate renal and liver function as indicated by:

∙ Serum creatinine ≤ 1.5 x upper limit of normal (ULN); if serum creatinine is \>1.5 x ULN, creatinine clearance must be ≥ 50 mL/min either by calculation or by measured 24-hour urine collection

‣ Total bilirubin ≤1.5 x ULN; If Gilbert's Syndrome may have Bilirubin\> 1.5 x ULN

‣ Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤3 x ULN of institution's normal range; for patients with known liver metastases, AST and ALT may be ≤ 5 x ULN.

‣ Coagulation: aPTT and PT≤ 1.3 x ULN

• Patients with brain metastases are eligible if clinically controlled that is defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function \& no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.

• Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug.

⁃ Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).

⁃ Willingness and ability to comply with study procedures and follow-up examination.