Trial intelligence / Profile preview

186RNL in Leptomeningeal Metastases

NCT07098806Phase 2

Key facts

Status: Recruiting
Start: Jul 2025
Primary completion: Jul 2027
Countries: 1
Sponsor: Cerenome
Modality: Nanoparticles

Drugs: rhenium (186Re) obisbemeda
Conditions: leptomeningeal metastasis (LM)

Overview

Phase 2, open-label, single-arm trial of rhenium (186Re) obisbemeda in leptomeningeal metastasis (LM), sponsored by Cerenome. Primary endpoints: Maximum Tolerated Dose at 13 months, Dose Distribution of 186RNL at 13 months and 1 more. Started Jul 2025; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Experimental: Multiple Doses
Multiple Doses of 186RNL

Who it enrols

Adults with leptomeningeal metastasis from a primary solid tumor, KPS 70-100, adequate organ function, and normal CSF flow. Excludes patients with recent prior therapies, whole brain radiation, or contraindications to intraventricular catheter.

Endpoints

Primary

Maximum Tolerated Dose13 months
Dose Distribution of 186RNL13 months
Safety and tolerability of multiple dose treatment13 months

Secondary

Objective Response Rate13 months
Overall Survival13 months
Dosimetry profile of 186RNL13 months
Neurologic Progression-Free Survival13 months
Neurologic status by NANO scale13 months

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