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NOT YET RECRUITING
NCT07674693
PHASE1

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

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2026-07

Completion Date

2031-07

Last Updated

2026-06-29

Healthy Volunteers

No

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