Testing SAIL66 in patients with specific solid tumors

A Phase I Open-label, Multicenter Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors

This study is testing a new drug called SAIL66 to see if it is safe and effective for people with certain advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 231 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chugai Pharmaceutical (Industry-sponsored)
• Drugs / interventions: obinutuzumab, tocilizumab
• Locations: 9 sites (Gilbert, Arizona and 8 other locations)
• Trial ID: NCT05735366 on ClinicalTrials.gov

What this trial studies

This Phase 1 study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SAIL66 in patients with CLDN6-positive locally advanced or metastatic solid tumors. The study will involve a dose-escalation and expansion approach to determine the optimal dosage and assess the drug's effects. Patients will be monitored closely for any adverse reactions and overall response to the treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with CLDN6-positive locally advanced or metastatic solid tumors.

Not a fit: Patients with primary central nervous system malignancies or those with a history of significant CNS disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with CLDN6-positive solid tumors.

How similar studies have performed: While this approach is novel, similar studies targeting specific biomarkers in solid tumors have shown promise in the past.

Eligibility 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 and for 3 months after the final dose of obinutuzumab.

Exclusion Criteria:

* Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, or within 18 months after the last dose of obinutuzumab, 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 this trial is running

Gilbert, Arizona and 8 other locations

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

Study contacts

• Study coordinator: Clinical trials information

Conditions Solid Tumor