A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

Key Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic or locally advanced, squamous or non-squamous NSCLC (NSCLC). Patients must have received no more than four prior lines of therapy, including a PD-1 / PD-L1-containing therapy and a platinum containing regimen. Patients must have received no more than one taxane containing regimen and no more than one investigational agent; 2. Must provide study-related tumor specimens; 3. ECOG(PS) 0-1; 4. Estimated Life Expectancy \> 3 months; 5. Adequate bone marrow (BM), renal, hepatic and metabolic function. Key Exclusion Criteria: 1. Concurrent cancer treatment with cytoreductive therapy, radiotherapy, cytokine therapy, cytotoxic agents, targeted small molecule therapy or any investigational anticancer small molecule drugs within 2 weeks prior to the start of study treatment (except 5 weeks from last dose of nitrosourea compound) OR treatment with monoclonal antibodies within 4 weeks prior to the start of study treatment; 2. Known symptomatic central nervous system (CNS) metastases requiring steroids. 3. Diagnosis of any other malignancy within 2 years prior to enrollment; 4. Vaccination within 4 weeks of the first dose of study treatment is prohibited except for administration of inactivated vaccines; 5. Current use of immunosuppressive medication at study entry; 6. Active or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent; 7. Acute or chronic infections requiring systemic therapy; 8. Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis; 9. Known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an AE leading to drug discontinuation; 10. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.