ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

Eligibility Criteria

• 1. ≥18 years of age at the time of informed consent.
• 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• 3. Wash out period from previous antitumor therapies
• 4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
• 5. Adequate organ function.
• 6. An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.
• 7. For Dose Escalation Phase Only: Patients with advanced or metastatic solid tumors, histologically or pathologically confirmed, who have progressed after all standard therapies, or for whom no further standard therapy exists.
• 8. No prior immunotherapy
• 1. Pregnant or breastfeeding females.
• 2. Childbearing potential who does not agree to the use of contraception during the treatment period.
• 3. Treatment with any investigational drug within washout period.
• 4. Prior treatment with an anti-CTLA-4 therapy.
• 5. History of significant immune-mediated AE.
• 6. Central nervous system (CNS) disease involvement.
• 7. History or risk of autoimmune disease.
• 8. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent).
• 9. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
• 10. Major surgery within 4 weeks prior to the first dose of the study drug.
• 11. Has had an allogeneic tissue/solid organ transplant.
• 12. Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.
• 13. A positive COVID-19 test within 14 days of Cycle 1 Day 1.