Solid tumor
Conditions
Interventions
SAIL66: intravenous administration(IV), Prescribed dose
Sponsors
Jane Royalty
Eligibility
Sex/Gender
All
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.
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, whichever is longer Primary central nervous system (CNS) malignancy, symptomatic (seizures etc.) CNS metastases, actively progressing 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Efficacy Evaluation of safety and tolerability based on NCI CTCAE Efficacy evaluation based on RECIST | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics, Phamacogenomics Evaluate the PK profile of SAIL66 Efficacy evaluation based on RECIST | — |
Countries
Japan, United States
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed