Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT05735366
Eligibility 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
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05735366
Study Brief:
Protocol Section:
NCT05735366