NCT05034497

Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases

A Multicenter Phase 1 Clinical Study to Determine the Maximum Tolerated Dose/Maximum Feasible Dose, Safety,& Efficacy of Single Dose Rhenium-186 NanoLiposome (186RNL) Administered Via Intraventricular Catheter for Leptomeningeal Metastases

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Plus Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase I clinical study that will administer a single dose of 186RNL via intraventricular catheter for treatment of Leptomeningeal Metastases (LM).

Detailed description

This Phase I clinical study evaluates a single dose of 186RNL (radionuclide clinical study drug) administered through an intraventricular catheter (Ommaya reservoir) in participants with Leptomeningeal Metastases (LM). The clinical study treatment consists of a single administered 5cc dose of 186RNL per participant. The clinical study will include the evaluation at separate dose levels. Three to six participants may be treated at each dose. The maximum number of participants to be enrolled in the study is 27. The clinical study treatment will be administered, following a CSF flow study, on an outpatient basis by the clinical study physician. Participants will be followed for up to 12 months after the clinical study drug is administered. The U.S. Food and Drug Administration (FDA) has not approved 186RNL for this specific disease.

Conditions

• Leptomeningeal Metastasis

Interventions

Type	Name	Description
DRUG	186RNL	All participants will be required to have an Ommaya Reservoir and a CSF Flow Study. Participants will receive a single 5cc dose of 186RNL via Ommaya Reservoir.

Timeline

• Start date: 2021-12-06
• Primary completion: 2025-12-21
• Completion: 2026-06-30
• First posted: 2021-09-05
• Last updated: 2025-03-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study