- Age ≥18 years (≥ 20 years in Japan)
- Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow function, renal and liver functions Phase 1b
- Histological or Cytological diagnosis of advanced solid tumor with clinical evidence
of response to anti-PD-1 or PD-L1 agent
- Participant must have received at least 1 prior line of therapy for recurrent or
metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to
standard therapy approved for the specific tumor type Phase 2
- Participants must have a documented diagnosis of stage III where participants are not
candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC
- EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not
permitted
- Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score [TPS]
≥1%) or unknown are eligible
- Up to 1 line of prior therapy in advanced disease settings allowed
- Participant should not have received prior treatment with anti PD-1/PD-L1 drugs
- At least one measurable lesion as defined by RECIST version 1.1
- Participants with known symptomatic brain metastases requiring steroids
- Baseline (defined as the timepoint prior to the first dose of drug, i.e screening or
Cycle 1 Day 1 (C1D1))12-lead electrocardiogram (ECG) that demonstrates clinically
relevant abnormalities that may affect participant safety or interpretation of study
results
- Hypertension that cannot be controlled by medications (eg, >150/90 mmHg) despite
optimal medical therapy
- Known or suspected hypersensitivity to active ingredient or excipients of the study
drug.
- History of Grade ?3 immune mediated AE (including AST/ ALT elevations that where
considered drug related and cytokine release syndrome [CRS]) that was considered
related to prior immune modulatory therapy (eg, immune checkpoint inhibitors,
co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b
only)