CompletedPhase 1

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

United States, Japan22 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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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