New targeted drug shows early promise for Hard-to-Treat cancers
NCT ID NCT05735366
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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22 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Jan 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
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Cancer Institute Hospital of JFCR
Tokyo, Koto Ku, 135-8550, Japan
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Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
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MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
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National Cancer Center Hospital
Tokyo, Chuo Ku, 104-0045, Japan
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National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
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Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777, Japan
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Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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