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- W4386948635 abstract "Albumin-bound (nab)-sirolimus, a novel mammalian target of rapamycin inhibitor (mTORi) that utilizes nanoparticle technology to preferentially target tumors, is approved in the United States for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). In AMPECT (NCT02494570), the registrational trial of nab-sirolimus in advanced malignant PEComa, most treatment-emergent adverse events (TEAEs) were grade 1/2 and manageable for long-term treatment; no grade ≥ 4 TEAEs were observed. In an exploratory analysis of AMPECT, 8/9 (89%) and 1/5 (20%) patients with TSC1 and TSC2 inactivating alterations, respectively, had confirmed responses (Wagner et al., J Clin Oncol, 2021). TSC1 and TSC2 are critical negative regulators of mTOR complex 1 activation, and inactivating alterations in TSC1 and/or TSC2 have been observed in several tumor types, including endometrial, ovarian, and cervical cancers. There are no approved treatment options specifically for patients with solid tumors harboring TSC1/TSC2 alterations." @default.
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- W4386948635 date "2023-09-01" @default.
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- W4386948635 title "Phase 2, multicenter, open-label basket trial of nab-sirolimus for patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes (PRECISION I) (1300)" @default.
- W4386948635 doi "https://doi.org/10.1016/j.ygyno.2023.06.204" @default.
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