A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Exclusion Criteria

• •1. Received any prior immunotherapy.
• •2. Received prior systemic anticancer therapy including investigational agents.
• •3. Received prior radiotherapy.
• •4. Received a live or live-attenuated vaccine .
• •5. Has received an investigational agent.
• •6. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
• •7. Known additional malignancy.
• •8. Known active CNS metastases and/or carcinomatous meningitis.
• •9. Active autoimmune disease.
• •10. History of (noninfectious) pneumonitis/interstitial lung disease.
• •11. Active, uncontrolled infection requiring systemic therapy.
• •12. Unable to swallow study drug or disease that interfere with proper absorption of study drug.
• •13. Significant cardiovascular disease.
• •14. Cerebrovascular accident.
• •15. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subject's ability to cooperate with the requirements of the study.
• •16. History of severe hypersensitivity to pembrolizumab and/or any of its excipients.
• •17. History of hypersensitivity to APX-343A and/or any of its excipients.
• •18. History of allogeneic tissue/solid organ transplant.
• •19. History of HIV infection or HIV positive at screening.
• •20. Subjects who have not adequately recovered from major surgery or have ongoing surgical complications.