Phase 1 Safety and Tolerability Study of Andes-1537 for Injection in Patients With Advanced Unresectable Solid Tumors

Inclusion Criteria

• •Men and women 18 years of age or older
• •Can understand and voluntarily sign an informed consent form prior to any study-related assessments or procedures, and are able to adhere to the study visit schedule and other protocol requirements
• •Patient with documented pathological evidence of a cancer from which has developed advanced unresectable solid tumors that are, in the opinion of their treating physician, refractory to standard therapy or for which no standard therapy is available
• •Consent to tumor biopsy from accessible tissue (optional in Part 1 and mandatory in Part 2)
• •Have measureable disease by RECIST
• •Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• •Have adequate organ function, confirmed by the following laboratory values obtained ≤ 3 days prior to the first treatment: absolute neutrophil count ≥ 1.5 × 10\^9/L; hemoglobin ≥ 9 g/dL; platelets ≥ 100 × 10\^9/L; aspartate transaminase and alanine transaminase ≤ 2.5 × upper limit of normal (ULN); serum total bilirubin ≤ 2.0 × ULN; serum creatinine ≤ 1.5 × ULN, or estimated or measured creatinine clearance ≥ 60 mL/min; prothrombin time, activated partial thromboplastin time ≤ 1.5 × ULN if not on anticoagulation therapy
• •Female patients of childbearing potential must have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug.
• •Male patients at screening must agree to practice adequate contraception from study entry through at least 6 months after discontinuation of study drug.