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

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b/2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phosplatin Therapeutics
• Collaborators: EMD Serono; Pfizer
• Treatments: Antibodies, Monoclonal; Avelumab

Criteria

Key Inclusion Criteria:

1. Histologically or cytologically proven metastatic or locally advanced disease. Specifically:

-patients with NSCLC, must have measurable disease by RECIST v1.1 criteria

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.