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

Chugai Pharmaceutical

Status and phase: Active, not recruiting; Phase 1

Conditions: Solid Tumor

Treatments: Drug: SAIL66

Study type: Interventional

Funder types: Industry

Identifiers

NCT05735366

SAL101JG

Details and patient eligibility

About

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.

Enrollment: 231 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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231 participants in 3 patient groups

Q3W Dose Escalation part

Experimental group

Description:

Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses.

Treatment:

Drug: SAIL66

Expansion part

Experimental group

Description:

Patients will receive SAIL66 as a IV infusion at the recommended dose.

Treatment:

Drug: SAIL66

QW Dose Escalation part

Experimental group

Description:

Patients will receive SAIL66 as a weekly IV infusion at escalated doses.

Treatment:

Drug: SAIL66