Plus Therapeutics announced on February 26, 2025, the completion of its ReSPECT-LM Phase 1 single-dose escalation trial. The trial successfully determined the Recommended Phase 2 Dose (RP2D) for Rhenium (186 Re) Obisbemeda in patients with leptomeningeal metastases (LM).
The Cohort 4 dose of 44.1 mCi was established as the RP2D, with no dose-limiting toxicities observed at this level. One patient at this dose achieved a complete response, evidenced by the eradication of tumor cells in the cerebrospinal fluid.
With the RP2D established, the company is advancing both a single-dose expansion Phase 2 trial and a multiple-dose Phase 1 trial. Plus Therapeutics is also engaging the U.S. Food & Drug Administration to define the optimal pivotal trial pathway.
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