ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
Trial Parameters
Brief Summary
This is a Phase 1b/2, open-label, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors. The study drug ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
Eligibility Criteria
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 of enrollment. If not available, a fresh tumor biopsy is acceptable. 7. 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. 8. Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients. Exclusion Criteria: 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