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

Inclusion Criteria:

1. Age >= 18 years at time of signing informed consent form (ICF)
2. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
3. Adequate hematologic and end-organ function
4. Life expectancy >= 12 weeks
5. Patients with histologic documentation of locally advanced, or metastatic solid tumor
6. [Dose-escalation Parts and Biopsy Parts]Refractory or resistant to standard therapies or standard therapies are not available
7. [Dose-escalation Parts and Expansion Part] Patients with confirmed availability of fresh tumor or representative tumor specimens
8. [Biopsy Parts] Patients with accessible lesion(s)

Exclusion Criteria:

1. Clinically significant cardiovascular or liver disease
2. Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug
3. Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).
4. 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.
5. Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
6. Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
7. Uncontrolled tumor-related pain
8. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
9. Active or history of clinically significant autoimmune disease
10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.

[Expansion Part]

1. Prior treatment with investigational product which has MoA of Treg depletion
2. Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1