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

Key Inclusion Criteria:

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;
Must provide study-related tumor specimens;
ECOG(PS) 0-1;
Estimated Life Expectancy > 3 months;
Adequate bone marrow (BM), renal, hepatic and metabolic function.

Key Exclusion Criteria:

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;
Known symptomatic central nervous system (CNS) metastases requiring steroids.
Diagnosis of any other malignancy within 2 years prior to enrollment;
Vaccination within 4 weeks of the first dose of study treatment is prohibited except for administration of inactivated vaccines;
Current use of immunosuppressive medication at study entry;
Active or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent;
Acute or chronic infections requiring systemic therapy;
Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis;
Known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an AE leading to drug discontinuation;
Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.