Leptomeningeal MetastasesPhase 1NCT07674693
Phase 1 Study of WBRT or PCSI With REYOBIQ for Leptomeningeal Metastases
A Phase 1 study testing 186RNL in people with Leptomeningeal Metastases, run by NYU Langone Health.
Trial summary
This Phase 1 study is designed to assess the safety, tolerability, and schedule feasibility of administering Rhenium-186 NanoLiposome (REYOBIQ) at different dosing intervals following whole brain radiotherapy (WBRT) or proton craniospinal irradiation (PCSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastases
- What is being tested?
- 186RNL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Cancer Trials Inbox contact
About this study
Official title: A Phase 1 Study to Determine the Safety and Tolerability of Whole Brain Radiotherapy (WBRT) or Proton Craniospinal Irradiation (PCSI) With Multiple Doses of Rhenium-186 NanoLiposome (186RNL, REYOBIQ) Administered Via Intraventricular Catheter for Leptomeningeal Metastases
This Phase 1 study is designed to assess the safety, tolerability, and schedule feasibility of administering Rhenium-186 NanoLiposome (REYOBIQ) at different dosing intervals following whole brain radiotherapy (WBRT) or proton craniospinal irradiation (PCSI).
- Conditions
- Leptomeningeal Metastases
- Being tested
- 186RNL
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
186RNLDrug
Also called REYOBIQ
Intraventricular injection via catheter. Patients will be assigned to three separate dosing schedules and once assigned they will remain on that dose level for up to 12 months (6 doses). Each dose will be 26.4 mCi, and participants will receive three doses for a total of 79.2 mCi. The time between doses will vary depending on the schedule (shown in table 1):
- Schedule 1: Every 56 days
- Schedule 2: Every 28 days
- Schedule 3: Every 14 days
| Study group | Role | What they receive |
|---|---|---|
| WBRT or PCSI followed by REYOBIQ | Experimental | Patients will undergo WBRT or PCSI; following WBRT or PCSI, patients will initiate REYOBIQ in 28 (+/- 7 days) days following a dose escalation scheme. Receives: Drug: 186RNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
The incidence of DLTs during the 28-day DLT window following any administration of REYOBIQ.
Measured: Up to Month 13 (28 Days Post-Final Dose)
Secondary outcomes (4)
Central Nervous System Progression-Free Survival (CNS PFS)
Defined as the time from first treatment to the date of leptomeningeal metastases (LM) progression or death from any cause, whichever occurs first.
Measured: Up to Year 5
Overall Survival (OS)
Defined as the time from first treatment to death from any cause.
Measured: Up to Year 5
Overall Response Rate (ORR)
Defined as the proportion of evaluable patients achieving a best overall response (complete or partial response) prior to progression.
Measured: Up to Year 5
Duration of Response (DoR)
Defined as the time from first treatment to the date of LM progression among responders.
Measured: Up to Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Yang, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674693
- Sponsor's protocol ID
- 25-01308
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jonathan.Yang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Determine the Safety and Tolerability of Whole Brain Radiotherapy (WBRT) or Proton Craniospinal Irradiation (PCSI) With Multiple Doses of Rhenium-186 NanoLiposome (186RNL, REYOBIQ) Administered Via Intraventricular Catheter for Leptomeningeal Metastases
- ClinicalTrials.gov ID
- NCT07674693
- Acronym / sponsor ID
- 25-01308
- Conditions
- Leptomeningeal Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study is designed to assess the safety, tolerability, and schedule feasibility of administering Rhenium-186 NanoLiposome (REYOBIQ) at different dosing intervals following whole brain radiotherapy (WBRT) or proton craniospinal irradiation (PCSI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WBRT or PCSI followed by REYOBIQ | Experimental | Drug: 186RNLPatients will undergo WBRT or PCSI; following WBRT or PCSI, patients will initiate REYOBIQ in 28 (+/- 7 days) days following a dose escalation scheme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 186RNLAlso: REYOBIQIntraventricular injection via catheter. Patients will be assigned to three separate dosing schedules and once assigned they will remain on that dose level for up to 12 months (6 doses). Each dose will be 26.4 mCi, and participants will receive three doses for a total of 79.2 mCi. The time between doses will vary depending on the schedule (shown in table 1): * Schedule 1: Every 56 days * Schedule 2: Every 28 days * Schedule 3: Every 14 days | Drug | WBRT or PCSI followed by REYOBIQ |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Up to Month 13 (28 Days Post-Final Dose)
The incidence of DLTs during the 28-day DLT window following any administration of REYOBIQ.
4 secondary outcomes
Central Nervous System Progression-Free Survival (CNS PFS)
Time frame: Up to Year 5
Overall Survival (OS)
Time frame: Up to Year 5
Overall Response Rate (ORR)
Time frame: Up to Year 5
Duration of Response (DoR)
Time frame: Up to Year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jonathan.Yang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cancer Trials Inbox contact
Jonathan Yang, MD, PhD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 186RNL in people with Leptomeningeal Metastases, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Yang, MD, PhD (2127316030, Jonathan.Yang@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Up to Month 13 (28 Days Post-Final Dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.