A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria

• Age ≥ 18 years at time of signing Informed Consent Form
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
• Patient must have tumor specimen available for central pathology review and confirmed as CLDN6-positive
• (For male patients) Agreement to stay abstinent or use contraceptive measures with female partners, and agreement to refrain from donating sprerm during the treatment

Exclusion Criteria

• Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, whichever is longer
• Primary central nervous system (CNS) malignancy, symptomatic (seizures etc.) CNS metastases or CNS metastases required any anti-cancer treatment
• History or presence of CNS disease such as stroke (e.g., subarachnoid hemorrhage or cerebral infarction), epilepsy, CNS vasculitis, neurodegenerative disease, aphasia, dementia or paresis
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites