Actinium Pharmaceuticals highlighted data from the completed Phase 1b combination trial of Actimab-A + CLAG-M in patients with relapsed or refractory acute myeloid leukemia – r/r AML – at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting June 8 – 11 in Toronto. Actimab-A has been studied as a single agent and in combination with chemotherapies and targeted therapies in Phase 1 and Phase 2 trials. Despite the high-risk profile of the patients on the study, the combination of Actimab-A + CLAG-M produced high rates of response and measurable residual disease negativity and improved survival outcomes across all patient subsets: across all dose levels, radiation doses for key organs were well below known tolerance levels with external beam radiation ; no safety signals for major organs such as liver, heart, kidneys, lungs and intestines were observed and a safety profile consistent with that expected in heavily pre-treated r/r AML patients given salvage therapy; a single 30-minute administration of Actimab-A results in rapid radiation delivery and clearance with peak concentration reached around 0.6 hours and undetectable in the blood by 48 hours after administration; the dose of 0.75 microCi/kg was identified as optimal for this combination therapy and will be further evaluated in the next stage of clinical development.
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