Phase 1 Study of WBRT or PCSI With REYOBIQ for Leptomeningeal Metastases

NCT07674693 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 25-01308
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Leptomeningeal Metastases

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-Limiting Toxicities (DLTs)

  The incidence of DLTs during the 28-day DLT window following any administration of REYOBIQ.

  Up to Month 13 (28 Days Post-Final Dose)

Secondary Outcomes (4)

• Central Nervous System Progression-Free Survival (CNS PFS)

  Up to Year 5

• Overall Survival (OS)

  Up to Year 5

• Overall Response Rate (ORR)

  Up to Year 5

• Duration of Response (DoR)

  Up to Year 5

Study Arms (1)

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.

Drug: 186RNL

Interventions

186RNL DRUG

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

Also known as: REYOBIQ

WBRT or PCSI followed by REYOBIQ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Ventriculo-peritoneal or ventriculo-atrial shunts or contraindications to placement of Ommaya reservoir.
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Jonathan Yang, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Yang, MD, PhD

CONTACT

2127316030; Jonathan.Yang@nyulangone.org

Cancer Trials Inbox

CONTACT

CancerTrials@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Requests should be directed to Jonathan.Yang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.