A Study of PSB205 in Subjects With Advanced Solid Tumors

Exclusion Criteria

• •1. Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
• •2. Grade 3 or Grade 4 irAEs related to prior cancer immunotherapy.
• •3. Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression. Subjects previously treated central nervous system metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 14 days prior to first dose of study drug are permitted to enroll.
• •4. Hypertension unable to be controlled to ≤Grade 2 with medication.
• •5. Any condition requiring systemic treatment with corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before first dose of study drug. Corticosteroids for topical use, nasal spray, and inhaled steroids are allowed. Systemic corticosteroids for prophylaxis of contrast allergy are permitted.
• •6. Prior treatment with a CTLA-4 inhibitor in combination with a PD-1 or PD-L1 inhibitor.
• •7. Systemic anti-cancer treatment (including investigational agents). This includes radiotherapy \<2 weeks before the first dose of study drug, ≤4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T cell engaging agents; (≤8 weeks for cell-based therapy or anti-tumor vaccine) or have not recovered from acute toxic effects from prior chemotherapy and radiotherapy.
• •8. Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
• •9. Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
• •10. Subjects with a history of organ transplant.
• •11. Hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.
• •12. Known human immunodeficiency virus (HIV) positive.
• •13. Subjects with any of the following cardiovascular conditions are excluded:
• •1. Acute myocardial infarction within 6 months before first dose of study drug.
• •2. Current or history of New York Heart Association Class III or IV heart failure.
• •3. Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• •14. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
• •15. Subject has a history of alcoholism or drug abuse within the past 6 months.
• •16. Vaccinations within 4 weeks of first dose of study drug.