ML-016 in Advanced Cancer With Lung and/or Liver Involvement

This is an open-label, multi-center, phase 1/2 dose-escalation and dose expansion study evaluating the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of ML-016 in participants with advanced solid tumors with lung and/or liver involvement (primary or metastatic disease).

Inclusion Criteria: 1. Age ≥18 years old on the day of signing the consent form 2. Histopathological or cytological confirmed diagnosis of advanced (locally advanced or metastatic) solid malignancy which is refractory to standard therapeutic options or for which no standard measures with curative intent or likelihood of disease control are available, or such measures are not acceptable to the participant. 3. Eastern Cooperative Oncology Group Performance Status ≤1 4. The participant has adequate baseline hematologic function, as demonstrated by the following: * Hemoglobin ≥8.0 g/dL , * Neutrophil count ≥1.5 x 109/L, * Platelets ≥75 x 109/L 5. The participant has adequate baseline kidney function, as demonstrated by the following: * Serum creatinine ≤1.5 x ULN, and/or * Calculated creatinine clearance ≥60 ml/min using the Cockroft-Gault formula or per institutional standard method 6. The participant has adequate baseline liver function, as demonstrated by the following: * Total bilirubin \470 ms and/or pacemaker), or prior diagnosis of congenital long QT syndrome 5. Left ventricular ejection fraction \