A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

• ≥ 18 years of age at the time of informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
• At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
• Adequate organ function.

Exclusion criteria

• Patients who meet any of the following criteria cannot be enrolled:

• Pregnant or breastfeeding females.
• Childbearing potential who does not agree to the use of contraception during the treatment period..
• Treatment with any investigational drug within washout period.
• Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
• Central nervous system disease involvement
• History or risk of autoimmune disease.
• History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation.
• Patients requiring systemic treatment with corticosteroids
• Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
• Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
• Major surgery within 4 weeks prior to the first dose of the study drug.
• Has had an allogeneic tissue/solid organ transplant.