A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Solid Tumors

Exclusion Criteria

• •1. Prior exposure to 4-1BB agonists.
• •2. Receipt of any anticancer investigational product or any approved drug(s) or biological products (except hormone-replacement therapy, testosterone or oral contraceptives) within 4 weeks prior to the first dose of study drug. Previous exposure to oral fluorouracils or small molecular targeted drugs require a minimum washout period of 2 weeks or 5 half-lives prior to the first dose of study drug (whichever is longer). Previous exposure to mitomycin C or nitrosourea requires a minimum washout period of 6 weeks prior to the first dose of study drug.
• •3. Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES101.
• •4. Primary or metastatic brain or meningeal tumors.
• •5. Patients with other malignancies previously or currently shall be excluded in Part B.
• •6. Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
• •7. Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.
• •8. Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug. Certain exceptions as defined in protocol apply.
• •9. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or immunosuppressive medications..
• •10. Subjects who received G-CSF, GM-CSF, Thrombopoietic drugs or EPO within 14 days prior to the first dose of the study drug.
• •11. Any evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
• •12. History of hepatitis (non-alcohol steatohepatitis, alcohol or drug-related, autoimmune) or cirrhosis.
• •13. Clinically significant cardiac condition.
• •14. History of pulmonary embolism within 12 weeks prior to the first dose of study drug.
• •15. Major surgery within 4 weeks prior to enrollment on this trial.
• •16. Systemic anti-infectious drug treatments within 4 weeks prior to the first dose of study drug.
• •17. Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.
• •18. Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
• •19. Subject has not recovered from all AEs of previous anticancer therapies to baseline or ≤ Grade 1 per CTCAE v5.0 before teh first dose of study drug. Certain exceptions as defined in protocol apply.
• •20. Pregnant or nursing females.
• •21. Any known, documented, or suspected history of substance abuse that would preclude subject from participation, unless clinically justified (i.e., will not interfere with study participation and/or will not compromise trial objectives) per judgment of the Investigator and with approval of the Medical Monitor or Study Director.
• •22. The subject is inappropriate to participate in this study for other reasons in the judgment of the Investigator.