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

Inclusion 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 ofenrollment. If not available, a fresh tumor biopsy is acceptable.

7. For Dose Escalation Phase Only: Patients with histologically or cytologicallyconfirmed, locally advanced or metastatic solid tumors, who have progressed afterall standard therapies, or for whom no further standard therapy exists.

8. Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment arerequired for all patients.

Exclusion Criteria:

1. Pregnant or breastfeeding females.

2. Childbearing potential who does not agree to the use of contraception during thetreatment period.

3. Treatment with any investigational drug within washout period.

4. Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4therapy with enhanced ADCC function.

5. History of significant irAEs or irAE.

6. Central nervous system (CNS) disease involvement.

7. History or risk of autoimmune disease.

8. Patients requiring systemic treatment with corticosteroids or otherimmunosuppressive 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, chronicobstructive 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 studytreatment. Has received a live or live-attenuated vaccine within 30 days prior tothe first dose of study treatment. Note: Administration of killed vaccines areallowed.

13. A positive COVID-19 test within 14 days of Cycle 1 Day 1.

14. History of Hypersensitivity or known to be allergic to protein drugs or recombinantprotein.

15. Active hemoptysis or central airway invasion by metastatic tumor.