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

NCT07674693 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-06-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Jonathan Yang, MD, PhD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-07-31
Completion
2031-07-31
FDA Drug
Yes

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07674693 on ClinicalTrials.gov