Spinal-Fluid injection targets Hard-to-Reach lung cancer spread
NCT ID NCT07702305
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This phase 1 trial tests an experimental drug, sacituzumab tirumotecan (SKB264), given directly into the spinal fluid of people with a specific type of lung cancer that has spread to the lining of the brain and spinal cord (leptomeningeal metastasis). The study enrolls adults whose cancer has stopped responding to standard targeted therapy. The goal is to find a safe dose and see if the drug can shrink the cancer in the central nervous system.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental antibody-drug conjugate called sacituzumab tirumotecan (SKB264), given as an injection into the spinal fluid
- What this could lead to
- If this works, it could offer a new treatment option for people with a hard-to-treat form of lung cancer that has spread to the lining of the brain and spinal cord.
- What could go wrong
- This is a very early, small trial (8-15 people) focused on finding the right dose and checking safety. It may not lead to a proven treatment, and there are risks like nerve damage and bone marrow suppression.
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
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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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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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.
Show the full entry requirements Hide 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; Pathologically diagnosed as EGFR mutation-positive non-small cell lung cancer; Leptomeningeal metastasis confirmed by detection of tumor cells in cerebrospinal fluid cytology; Previously received targeted therapy against EGFR mutation and progressed; ECOG performance status ≤ 3; Neurological symptoms stable for more than 7 days (defined as no new or worsening neurological symptoms and no more than a 1-point change in ECOG score); If radiotherapy (including whole-brain radiotherapy, stereotactic radiotherapy, etc.) has been received, at least 7 days after completion; if other intrathecal therapy has been received, a washout period of at least 7 days; Absolute neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 80 g/L, platelet count ≥ 75 × 10⁹/L; Prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 × upper limit of normal; Total bilirubin ≤ 1.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (elevations of total bilirubin and transaminases caused by tumor may be relaxed to 3× and 5×, respectively), creatinine ≤ 2 × upper limit of normal; calculated creatinine clearance ≥ 50 mL/min. Exclusion Criteria: Active infectious disease within 7 days before the start of study drug treatment; ECOG performance status ≥ 4; History of allergy to any component of the study drug; History of severe hypersensitivity reaction to any monoclonal antibody; Patients currently participating in other interventional studies; Previous or current severe immunodeficiency disease; Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.