CompletedPhase 1

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

United States22 participantsStarted 2023-04-17

Plain-language summary

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 participate

Age range18 Years

SexALL

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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

What they're measuring

Adverse events of SAIL66[safety and tolerability]

Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)

Change from baseline in vital signs[safety and tolerability]

Timeframe: From screening until study completion or treatment discontinuation (approximately 18 weeks)

Change from baseline in clinical laboratory test results and examination findings[safety and tolerability]

Timeframe: From screening until study completion or treatment discontinuation (approximately 18 weeks)

Dose-limiting toxicities (DLTs) of SAIL66[safety and tolerability]

Timeframe: From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)

Preliminary anti-tumor activity of SAIL66 when administered at selected dose(s) in each cohort [Expansion part]

Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (approximately 18 weeks)

Trial details

NCT IDNCT05735366

SponsorChugai Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-26

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