Plus Therapeutics, Inc. 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 (186Re) Obisbemeda in patients with leptomeningeal metastases (LM).
The RP2D was established as 44.1 mCi, with no dose-limiting toxicities observed at this level. Notably, one patient at the Cohort 4 dose achieved a complete response, evidenced by the eradication of tumor cells in the cerebrospinal fluid.
With the RP2D established, the company is now advancing both a single-dose expansion Phase 2 trial and a multiple-dose Phase 1 trial of 44.1 mCi fractionated into three doses. These next steps aim to further assess safety and efficacy and define the optimal pivotal trial pathway with the FDA.
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