A phase 1 study of SAIL66 in patients with CLDN6-positive locally advanced or metastatic solid tumors

JRCT ID: jRCT2031220588

Registered date:22/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid tumor
• Date of first enrollment: 18/04/2023
• Target sample size: 178
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

SAIL66: intravenous administration(IV), Prescribed dose
Tocilizumab: intravenous administration(IV), Prescribed dose

Outcome(s)

Primary Outcome

Safety, Efficacy
Evaluation of safety and tolerability based on NCI CTCAE
Efficacy evaluation based on RECIST

Secondary Outcome

Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics, Phamacogenomics
Evaluate the PK profile of SAIL66
Efficacy evaluation based on RECIST

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Jane Royalty