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

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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 and for 3 months after the final dose of obinutuzumab.

EXCLUSION CRITERIA

Exclusion Criteria:

Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, or within 18 months after the last dose of obinutuzumab, 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