RecruitingPhase 2NCT06534762

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

Efficacy and Safety of Milaberon in Combination With Standard Therapy in Advanced Solid Tumors: an Open, Multicenter, Clinical Study


Sponsor

Zhejiang Provincial People's Hospital

Enrollment

260 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called milaberon — given as a first-ever systemic (full-body) treatment — in adults aged 18 to 65 with advanced solid tumors (cancers in organs like lung, breast, colon, etc.) that cannot be surgically removed and have spread to other parts of the body. This early study focuses on safety, the right dosing, and early signs of whether the drug is working against different cancer types. **You may be eligible if...** - You are 18 to 65 years old - You have a confirmed advanced or metastatic solid tumor that cannot be surgically removed - You have not previously received any systemic (full-body) anti-cancer drug treatment for your metastatic cancer - You have at least one measurable tumor on a scan - You are in good health (ECOG 0-1) with expected survival of at least 12 weeks - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - You have received prior systemic treatment for metastatic disease (previous neoadjuvant/adjuvant therapy is allowed if it ended more than 6 months ago) - Your cancer is not measurable on standard scans - You have unresolved significant side effects from prior treatments - You have serious organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMirabegron

To explore the efficacy and safety of milaberon combined with standard treatment in advanced solid tumors


Locations(1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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NCT06534762


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