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).
≥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.
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.
Adagene Inc
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator