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New targeted drug shows early promise for Hard-to-Treat cancers

NCT ID NCT05735366

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called SAIL66 in 22 adults with advanced solid tumors that have a specific protein (CLDN6). The main goals were to check safety, find the right dose, and see if the drug can shrink tumors. While not a cure, the approach aims to control the disease in patients who have limited options.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Apr 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Cancer Institute Hospital of JFCR

    Tokyo, Koto Ku, 135-8550, Japan

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912, United States

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • National Cancer Center Hospital

    Tokyo, Chuo Ku, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • Shizuoka Cancer Center

    Shizuoka, Sunto-gun, 411-8777, Japan

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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