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
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
- lead OTHER
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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