Clinical Trials Logo
  1. Home
  2. Leptomeningeal Metastasis
  3. NCT05034497

Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases — ReSPECT-LM  

Leptomeningeal Metastasis Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05034497
Study type Interventional
Source Plus Therapeutics
Contact Melissa Moore, PhD
Phone 1-347-570-3338
Email MMoore@plustherapeutics.com
Status Recruiting
Phase Phase 1
Start date December 6, 2021
Completion date June 30, 2026
View Details
See also
  Status Clinical Trial Phase
Terminated NCT05414123 - A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Completed NCT04178343 - Tomotherapy for Leptomeningeal Metastases N/A
Recruiting NCT06399926 - Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir
Recruiting NCT04425681 - Osimertinib With Bevacizumab for Leptomeningeal Metastasis From EGFR-mutation Non-Small Cell Lung Cancer Phase 2
Recruiting NCT05598853 - Intrathecal Double Checkpoint Inhibition Phase 1
Recruiting NCT02803619 - A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis N/A
Recruiting NCT05746754 - Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis N/A
Not yet recruiting NCT04148898 - Osimertinib With or Without Bevacizumab for EGFR- Mutant Non-small Cell Lung Cancer With Leptomeningeal Metastasis Phase 2
Completed NCT04420598 - DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease Phase 2
Completed NCT02071056 - Circulating Tumor DNA in Cerebrospinal Fluid as an Early Biomarker of Leptomeningeal Metastasis (LM)
Recruiting NCT05385185 - Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer Phase 2
Terminated NCT04729348 - Pembrolizumab And Lenvatinib In Leptomeningeal Metastases Phase 2
Recruiting NCT06304441 - Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer N/A
Not yet recruiting NCT06296745 - Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. Phase 2
Recruiting NCT04778800 - A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY) N/A
Not yet recruiting NCT06282874 - Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases Phase 4
Not yet recruiting NCT04356222 - Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis Phase 4
Not yet recruiting NCT04356118 - Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis Phase 4
Not yet recruiting NCT05805631 - Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC Phase 2