BREAKING NEWS: ReSPECT-LM Phase 1 Single Dose Completed – Phase 2 Dose Determined
We are thrilled to announce a major milestone in the ReSPECT-LM clinical trial! The Phase 1 single-dose portion of the trial is now complete, and the recommended Phase 2 dose (RP2D) for single administration therapy has been determined.
This marks a critical step forward in our mission to develop Rhenium (186Re) Obisbemeda, a targeted radiotherapeutic for leptomeningeal metastases (LM)—a devastating and aggressive form of metastatic cancer affecting the central nervous system.
The ReSPECT-LM single-dose escalation trial assessed the safety, tolerability, and potential efficacy of intrathecally administered Rhenium (186Re) Obisbemeda in patients with leptomeningeal metastases (LM). Enrollment in Cohort 6 was recently completed (75.0 mCi). The Cohort 4 dose (44.1 mCi) was determined to be the RP2D; no dose-limiting toxicities were observed at this dose level. One patient at the Cohort 4 dose was observed to have achieved a complete response, as evidenced by the eradication of tumor cells in the cerebrospinal fluid—a key therapeutic endpoint.
“With the RP2D established, we are advancing both a single dose-expansion Phase 2 trial and a multiple-dose Phase 1 trial of 44.1 mCi fractionated into three doses to further assess safety and efficacy,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “We remain on track to complete enrollment in both trials this year and are simultaneously engaging the U.S. Food & Drug Administration to define the optimal pivotal trial pathway.”
With this progress, Plus Therapeutics is now preparing for the next phase of clinical development, bringing us closer to potential new treatment options for LM patients with limited therapeutic choices.
🔬 Learn more about ReSPECT-LM and our groundbreaking work in CNS oncology:
📢 Full Press Release: Read here
📄 About ReSPECT-LM: Learn more
#ClinicalTrials #OncologyResearch #LeptomeningealMetastases #NeuroOncology #BrainCancer #CancerBreakthroughs #MedicalInnovation #PSTV
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