This study is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, PK, and PD of ADU-1604 and explore initial clinical activity in adults with metastatic melanoma.
Single Group Assignment
There is one SNP
Subjects must have BRAF mutation status confirmed; if a subject is BRAF V600E/K positive, they must have received a BRAF- targeted regimen prior to entering the study, unless the patient was deemed ineligible for such treatment 4. Measurable disease according to RECIST (v1.1) [NOT required during Dose Escalation] 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Exclusion Criteria: 1. Prior diagnosis of uveal or mucosal melanoma 2. Prior treatment with CTLA-4-directed therapy in the metastatic setting. --- V600E ---