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
- Patients with CLDN6 positive solid tumors
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Solid Tumor
Age
18+
Phase
PHASE1
Participants Needed
184
Est. Completion Date
Dec 31, 2028
Treatment Type
INTERVENTIONAL
Sponsor
Chugai Pharmaceutical
ClinicalTrials.gov NCT Identifier
NCT05735366
Study Number
SAL101JG
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