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

This is a Phase 1 dose-escalation and expansion study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of SAIL66 in patients with CLDN6-positive locally advanced or metastatic solid tumors.

Inclusion Criteria:Age ≥ 18 years at time of signing Informed Consent FormEastern Cooperative Oncology Group (ECOG) PS of 0 or 1Patient must have tumor specimen available for central pathology review and confirmed as CLDN6-positiveExclusion Criteria:Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, whichever is longerPrimary central nervous system (CNS) malignancy, symptomatic (seizures etc.) CNS metastases or CNS metastases required any anti-cancer treatmentHistory or presence of CNS disease such as stroke (e.g., subarachnoid hemorrhage or cerebral infarction), epilepsy, CNS vasculitis, neurodegenerative disease, aphasia, dementia or paresisUncontrolled tumor-related painUncontrolled pleural effusion, pericardial effusion, or ascites