This is a Phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.
Age >= 18 years at time of signing informed consent form (ICF)
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
Adequate hematologic and end-organ function
Life expectancy >= 12 weeks
Clinically significant cardiovascular or liver disease
Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug
Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).
All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline.