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

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.

NCT Number	NCT06534762
Lead Sponsor	Zhejiang Provincial People's Hospital
Conditions	NSCLC, SCLC, Colorectal Cancer, Pancreas Cancer, TNBC - Triple-Negative Breast Cancer, DLBCL - Diffuse Large B Cell Lymphoma, Squamous Cell Carcinoma of Head and Neck
Enrollment	260 participants
Start Date	2024-07-15
Primary Completion	2026-07-01 (estimated)
Study Completion	2028-07-01 (estimated)
Updated on ClinicalTrials.gov	2024-08-02