Plus Therapeutics initiates part B of phase 1/2a ReSPECT-LM trial for leptomeningeal metastase
Plus Therapeutics has announced that the first patient has begun treatment in part B of the ReSPECT-LM phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumours.
The company has shared positive data from part A of the trial, which was presented at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference in August 2023. The data showed that ten patients were treated with a maximum absorbed dose of 85 Gray (GY) and up to 26.4mCi of radiation activity; no dose limiting toxicities were observed or the maximum feasible dose has not yet been reached; cerebrospinal fluid (CSF) tumour cell counts decreased an average of 53% measured at 28 days post treatment; and five of the ten patients treated in part A are alive, with the median overall survival being ten months.
Norman LaFrance, MD, chief medical officer of Plus Therapeutics, commented: “The Phase 1/Part A data in the ReSPECT-LM clinical trial is encouraging. In Phase 1/Part B, we plan to dose escalate to the maximum tolerated single dose while simultaneously collaborating with the US Food and Drug Administration (FDA) to implement multiple dosing into the trial.”
The drug has been granted Fast Track Designation by the FDA.
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