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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Leptomeningeal Metastases
• Intervention / Treatment: Drug: 186RNL

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Cancer Trials Inbox; Email: CancerTrials@nyulangone.org
• Study Contact Backup: Name: Jonathan Yang, MD, PhD; Phone Number: 2127316030; Email: Jonathan.Yang@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: WBRT or PCSI followed by REYOBIQ; 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; 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; Other Names: REYOBIQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Year 5
Overall Survival (OS)	Defined as the time from first treatment to death from any cause.	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.	Up to Year 5
Duration of Response (DoR)	Defined as the time from first treatment to the date of LM progression among responders.	Up to Year 5

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jonathan Yang, MD, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Meningeal Neoplasms; Central Nervous System Neoplasms; Meningeal Carcinomatosis
• Other Study ID Numbers: 25-01308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No