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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: NSCLC Cohort: Evaluate best overall response rate (ORR) by tumor type according to Immune-Response Criteria (iRECIST) in metastatic or locally advanced

Primary Outcome 1 - Timeframe: 24 months

Primary Outcome 2 - Measure: squamous or non-squamous NSCLC.

Primary Outcome 2 - Timeframe: N/A

CONDITION

• Non-Small Cell Lung Cancer (NSCLC)

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Daniel D Karp, MD

Role: Principal Investigator

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION