Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study

Summary

This study is an exploratory study, and all the drugs involved are listed drugs. The dosage of mirabetron is selected according to the basis of previous research. The clinical recommend dose of this product is 50mg/day, and the dose used in this study is 100mg/day, which is larger than the clinical commonly used dose. The main adverse reactions of this product are urinary tract infection and rapid heartbeat. In the clinical study, we will focus on the urine routine and heart-related adverse events of the subjects, and deal with the adverse events in time. Subjects were given mirabeeron 100mg/day orally once a day in the morning until disease progression. When there are related or possible related side effects of the study drug mirabeeron, and according to NCI-CTCAE V 5.0, when subjects have more than or equal to grade 3 related toxicity, the administration should be delayed until grade 2 or lower to baseline, and the dose will be reduced by 50%, and subsequent dose increase is not allowed. If the pre-dose criteria are not met within 28 days, the drug will be permanently discontinued.

Timeline

Start

2024-07-15

Primary completion

2026-07-01

Completion

2028-07-01

Publications

• Background Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
• Background Zheng RS, Chen R, Han BF, Wang SM, Li L, Sun KX, Zeng HM, Wei WW, He J. [Cancer incidence and mortality in China, 2022]. Zhonghua Zhong Liu Za Zhi. 2024 Mar 23;46(3):221-231. doi: 10.3760/cma.j.cn112152-20240119-00035. Chinese.
• Background Vasan N, Baselga J, Hyman DM. A view on drug resistance in cancer. Nature. 2019 Nov;575(7782):299-309. doi: 10.1038/s41586-019-1730-1. Epub 2019 Nov 13.
• Background Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013.
• Background Wang R, Hu Q, Wu Y, Guan N, Han X, Guan X. Intratumoral lipid metabolic reprogramming as a pro-tumoral regulator in the tumor milieu. Biochim Biophys Acta Rev Cancer. 2023 Sep;1878(5):188962. doi: 10.1016/j.bbcan.2023.188962. Epub 2023 Aug 2.
• Background Jin HR, Wang J, Wang ZJ, Xi MJ, Xia BH, Deng K, Yang JL. Lipid metabolic reprogramming in tumor microenvironment: from mechanisms to therapeutics. J Hematol Oncol. 2023 Sep 12;16(1):103. doi: 10.1186/s13045-023-01498-2.
• Background Seki T, Yang Y, Sun X, Lim S, Xie S, Guo Z, Xiong W, Kuroda M, Sakaue H, Hosaka K, Jing X, Yoshihara M, Qu L, Li X, Chen Y, Cao Y. Brown-fat-mediated tumour suppression by cold-altered global metabolism. Nature. 2022 Aug;608(7922):421-428. doi: 10.1038/s41586-022-05030-3. Epub 2022 Aug 3.
• Background O'Mara AE, Johnson JW, Linderman JD, Brychta RJ, McGehee S, Fletcher LA, Fink YA, Kapuria D, Cassimatis TM, Kelsey N, Cero C, Sater ZA, Piccinini F, Baskin AS, Leitner BP, Cai H, Millo CM, Dieckmann W, Walter M, Javitt NB, Rotman Y, Walter PJ, Ader M, Bergman RN, Herscovitch P, Chen KY, Cypess AM. Chronic mirabegron treatment increases human brown fat, HDL cholesterol, and insulin sensitivity. J Clin Invest. 2020 May 1;130(5):2209-2219. doi: 10.1172/JCI131126.
• Background Sun X, Sui W, Mu Z, Xie S, Deng J, Li S, Seki T, Wu J, Jing X, He X, Wang Y, Li X, Yang Y, Huang P, Ge M, Cao Y. Mirabegron displays anticancer effects by globally browning adipose tissues. Nat Commun. 2023 Nov 22;14(1):7610. doi: 10.1038/s41467-023-43350-8.

Drugs

Indications