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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

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Trial Profile

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: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 May 2024

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At a glance

  • Drugs Rhenium (186Re) obisbemeda (Primary)
  • Indications Meningeal carcinomatosis
  • Focus Adverse reactions
  • Acronyms ReSPECT-LM
  • Sponsors Plus Therapeutics
  • Most Recent Events

    • 15 May 2024 According to a Plus Therapeutics media release, FDA granted ReSPECT-LM Type C meeting for a multi-dose Phase 1 dose escalation study, scheduled for June 10, 2024. Company Complete ReSPECT-LM Phase 1 dose escalation trial enrollment, determine the maximum tolerated and recommended Phase 2 dose, and determine the multiple dosing regime.
    • 15 May 2024 According to a Plus Therapeutics media release, company planned comprehensive update on the Phase 1 dose escalation ReSPECT-LM trial for leptomeningeal metastases at SNO Annual Conference (November 22-26, 2024).
    • 15 May 2024 According to a Plus Therapeutics media release, abstracts submitted to present ongoing clinical study update for initial safety and feasibility from phase 1 dose escalation of Rhenium (186Re) obisbemeda (186RNL) for the treatment of leptomeningeal metastases, at SNO/ASCO (Society for Neuro-Oncology / American Society of Clinical Oncology) CNS Metastases Conference (August 8-10, 2024).
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