Radioactive nanoparticles target cancer in the Brain's lining
NCT ID NCT07674693
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This study tests a radioactive drug called Rhenium-186 NanoLiposome (REYOBIQ) given directly into the brain's fluid space, combined with whole brain or proton radiation. It is for people with leptomeningeal metastases, where cancer has spread to the lining of the brain and spinal cord. The goal is to find a safe dosing schedule and see if it can help control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rhenium-186 NanoLiposome (REYOBIQ)
- What this could lead to
- If successful, this could provide a new treatment option for people with leptomeningeal metastases, a serious spread of cancer to the brain and spinal cord lining.
- What could go wrong
- This is an early Phase 1 trial with only 29 participants, so safety and effectiveness are not yet proven. The treatment involves radiation and a radioactive drug, which may cause side effects.
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 29 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * At least 18 years of age at screening * Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB * Proven and documented LM evidenced by positive CSF cytology or CSF circulating tumor cells, from any primary solid tumor * Patients may have received prior chemotherapy regimens and prior radiation (there is no limit) * Karnofsky performance status of 60 to 100 * Acceptable liver function: * Bilirubin ≤ 1.5 times upper limit of normal * AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal for subjects with normal liver * AST (SGOT) and ALT (SGPT) ≤ 5.0 times upper limit of normal for subjects with liver metastasis * Subjects with a creatinine clearance greater than or equal to 60 mL/min (using the Cockcroft-Gault Equation) for males and females. * Acceptable hematologic status (without hematologic support): * ANC ≥ 1000 cells μL * Platelet count ≥ 75,000/μL * Hemoglobin ≥ 9.0 g/dL * PT/INR and PTT ≤1.5 x ULN, unless treated with anticoagulants * All women of childbearing potential must have a negative serum pregnancy test at screening. Male and female subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose. Exclusion Criteria: * The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v6.0) Grade ≤ 1 from AEs due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study. Prior AEs due to alopecia, anemia, and lymphopenia are not required to be recovered to Grade ≤ 1 prior to 186RNL treatment, assuming other inclusion criteria are satisfied. * Ventriculo-peritoneal or ventriculo-atrial shunts or contraindications to placement of Ommaya reservoir. * Females of childbearing potential who are pregnant, breast feeding, or may possibly be pregnant without a negative serum pregnancy test (see inclusion criteria). * Serious intercurrent illness, clinically significant cardiac arrhythmias, uncontrolled systemic infection, symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug, myocardial infarction, stroke, transient ischemic attack within 6 months, seizure disorder with any seizure occurring within 14 days prior to consenting or encephalopathy. * Active severe non hematologic organ dysfunction such as renal, cardiac, hepatic, pulmonary, or gastrointestinal grade 3 or above. * Toxicity from prior treatments (grade 3 or above) that have not subsided to grade 1. * Patients with prior CNS directed EBRT. * Cytotoxic systemic therapy is excluded if given within 14 days or 5 half-lives, whichever is shorter, prior to 186RNL treatment. Small-molecule kinase inhibitors, targeted therapies, immunotherapy, and hormonal therapy can be given up to the day of treatment per investigator discretion. * Projected survival of less than 60 days.
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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