A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors

Inclusion Criteria

• 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
• Patients with histologic documentation of locally advanced, or metastatic solid tumor
• [Dose-escalation Parts and Biopsy Parts]Refractory or resistant to standard therapies or standard therapies are not available
• [Dose-escalation Parts and Expansion Part] Patients with confirmed availability of fresh tumor or representative tumor specimens
• [Biopsy Parts] Patients with accessible lesion(s)

Exclusion Criteria

• 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.
• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
• Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Active or history of clinically significant autoimmune disease
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. [Expansion Part]
• Prior treatment with investigational product which has MoA of Treg depletion
• Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1