RNL (rhenium (186Re) obisbemeda)

P1, N=40, Not yet recruiting, Plus Therapeutics | Trial completion date: Jan 2025 --> Mar 2028 | Trial primary completion date: Jan 2025 --> Mar 2028

"Company acquired assets for the synergistic leptomeningeal metastases (LM) diagnostic platform, 'CNSide' and discussed potential partnering opportunities....Plus presented topline clinical trial data from the FORESEE trial which met its primary endpoint of clinical utility for the CNSide test in 40 patients with LM due to either breast or non-small cell lung cancer; a presentation of the full analysis is planned for the August 8-10 SNO/ASCO Meeting in Denver, CO."

Background: We have previously shown a dose-dependent association with survival for patients receiving Rhenium-186-nanoliposome (186RNL) for rGBM... MRI radiographic features proved valuable in assessing treatment efficacy and guiding treatment considerations. Image processing is ongoing, and the complete data set will be presented.

186RNL therapy resulted in a dose and volume dependent impact on OS without significant toxicity. Based on these data, the Cohort 6 non-DLT dose advanced to Phase 2. Study progress will be reported.

A single administration of 186RNL by CED in recurrent glioma patients is feasible, safe, and potentially effective in increasing overall survival when > 100Gy radiation is delivered to the tumor. A RP2D of 22.3mCi in 8.8mL was selected for patients with tumor size of ≤20mL in the planned Phase 2B.

Adjuvant MHT may induce tumor radio-sensitization, immune cell recruitment, and survival benefit when combined with CRT. Optimization of the combination therapy treatment scheme is required.

Based on prior work establishing the comparability of a bevacizumab (Bev) comparator to inform early-phase CED study results, OS of the 15 TAD patients were compared to a Bev ECA. Single-arm studies can be challenging to interpret. By comparing the ReSPECT-GBM outcomes to an ECA of similar patients with balanced baseline characteristics, we can better appreciate the treatment effect of 186RNL administered via CED. The current results are encouraging, and updated results reflecting current follow-up will be presented at the meeting.

"Plus Therapeutics, Inc...and Biocept, Inc...announce a multi-year agreement to employ Biocept’s cerebrospinal fluid (CSF) assay CNSide1 in Plus Therapeutics’ ReSPECT-LM Phase 1/2a dose-escalation clinical trial of Rhenium-186 NanoLiposome (186RNL) for the treatment of patients with leptomeningeal metastases (LM), which is cancer in the membranes that surround the brain and spinal cord."