A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT05735366

Run by

Chugai Pharmaceutical

People needed

22

Starts

2023-04-17

Expected to finish

2026-01-26

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
• MUSC Hollings Cancer Center — Charleston, South Carolina, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• National Cancer Center Hospital East — Kashiwa, Chiba, Japan
• National Cancer Center Hospital — Tokyo, Chuo Ku, Japan
• Cancer Institute Hospital of JFCR — Tokyo, Koto Ku, Japan
• Shizuoka Cancer Center — Shizuoka, Sunto-gun, Japan

Full record on ClinicalTrials.gov

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