A phase 1 study of SAIL66 in patients with CLDN6-positive locally advanced or metastatic solid tumors
- Conditions
- Solid tumor
- Registration Number
- JPRN-jRCT2031220588
- Lead Sponsor
- Jane Royalty
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 178
Age >= 18 years at time of signing Informed Consent Form
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
Patients with CLDN6 positive solid tumors
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Efficacy<br>Evaluation of safety and tolerability based on NCI CTCAE<br>Efficacy evaluation based on RECIST
- Secondary Outcome Measures
Name Time Method Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics, Phamacogenomics<br>Evaluate the PK profile of SAIL66<br>Efficacy evaluation based on RECIST