这是一项第一期b／第二期、开放标签、剂量递增、剂量扩展及剂量优化研究，旨在评估ADG126-pembrolizumab联合方案在晚期／转移性实体瘤患者中的安全性、耐受性、药物动力学及免疫原性。 研究药物ADG126是一种抗CTLA-4全人源单克隆抗体，特异性结合人类CTLA-4。Pembrolizumab是一种PD-1受体阻断抗体（人源化IgG4单克隆抗体）。
适应症：Advanced/Metastatic Solid Tumors
入组条件
纳入标准
- ≥18 years of age at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Wash out period from previous antitumor therapies
- At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
- Adequate organ function.
- An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.
- For Dose Escalation Phase Only: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
- Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients.
排除标准
- 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.
- Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function.
- History of significant irAEs or irAE.
- Central nervous system (CNS) disease involvement.
- History or risk of autoimmune disease.
- Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent).
- 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.
- 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.
- A positive COVID-19 test within 14 days of Cycle 1 Day 1.
- History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein.
- Active hemoptysis or central airway invasion by metastatic tumor.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。