ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors

ADG126 is a novel anti-CTLA-4 fully human IgG1 antibody prodrug that is modified with Adagene Safebody technology to control the activation of anti-CTLA4 activity.ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb which is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG126 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.

Inclusion criteria

• Adults ≥18 years of age.
• ECOG performance status 0 or 1.
• Estimated life expectancy of more than 12 weeks .
• Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented, 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.
• Meets the additional tumor type requirements as specified in Protocol.

Exclusion criteria

• Treatment with any investigational drug within washout period.
• Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
• History of significant immune-mediated AE.
• Central nervous system (CNS) disease involvement.
• Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
• Clinically significant cardiac disease.
• Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
• Patients who received:

• A COVID-19 vaccine within 7 days of Cycle 1 Day 1.
• Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day 1.
• Known active infection of HBV/BCV/HIV.
• Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
• Second primary malignancy not in remission for greater than 3 years.
• History(within the last 5 years) or risk of autoimmune disease.
• Pregnant or breastfeeding females.
• Childbearing potential who does not agree to the use of contraception during the treatment period.