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OncoMatch/Clinical Trials/NCT06534762

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

Is NCT06534762 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Mirabegron for nsclc.

Phase 2RecruitingZhejiang Provincial People's HospitalNCT06534762Data as of May 2026

Treatment: MirabegronThis 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Small Cell Lung Cancer

Colorectal Cancer

Pancreatic Cancer

Triple-Negative Breast Cancer

Breast Carcinoma

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Head and Neck Squamous Cell Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic antitumor drug therapy

Exception: adjuvant/neoadjuvant therapy completed >6 months before relapse or progression

Has not received previous systemic antitumor drug therapy for metastatic/recurrent solid tumors; For subjects who have previously received neoadjuvant/adjuvant therapy, it takes more than 6 months from the last treatment to relapse or progression

Cannot have received: radiotherapy

Exception: within 4 weeks before treatment

Received the following treatment within 4 weeks before treatment: radiotherapy of tumor

Cannot have received: major surgical operation

Exception: within 4 weeks before treatment or wound not completely healed

major surgical operation or wound has not been completely healed

Cannot have received: β3 adrenoceptor agonist and corresponding clinical research drugs

Exception: within 4 weeks before treatment

β3 adrenoceptor agonist and corresponding clinical research drugs

Cannot have received: live attenuated vaccine

Exception: within 28 days prior to the first administration

received treatment with live attenuated vaccine within 28 days prior to the first administration of the study drug

Lab requirements

Blood counts

absolute value of neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin concentration ≥ 9g/dL

Kidney function

serum creatinine ≤ 1.5 ×ULN, or creatinine clearance rate (CCr)≥ 60 ml/min

Liver function

bilirubin ≤ 1.5 × ULN; aspartate aminotransferase and glutamate aminotransferase ≤ 2.5 ×ULN, AST and ALT ≤ 5 ×ULN in case of liver metastasis

The function of major organs is normal, I .e. the following criteria are met (no blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor [CSF] treatment has been received within 14 days before the first study drug administration): blood test (absolute value of neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin concentration ≥ 9g/dL); Liver function test (bilirubin ≤ 1.5 × ULN; aspartate aminotransferase and glutamate aminotransferase ≤ 2.5 ×ULN, AST and ALT ≤ 5 ×ULN in case of liver metastasis); renal function (serum creatinine ≤ 1.5 ×ULN, or creatinine clearance rate (CCr)≥ 60 ml/min); coagulation function, international normalized ratio (INR)≤ 1.5 ×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤ 1.5 ×ULN; thyroid function, thyroid-stimulating hormone (TSH)≤ the upper limit of normal (ULN); FT3 and FT4 levels should be examined if abnormal, and FT3 and FT4 levels are normal

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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