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New treatment option for NSCLC
Official title Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study
ClinicalTrials.gov ID: NCT06534762
What this study is testing
What is Mirabegron?
Mirabegron is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients voluntarily participate in the study, sign informed consent, and have good compliance;
- 18-65 years old (including 18 and 65 years old);
- solid tumors confirmed by histology and/or cytology, and advanced metastatic tumors that are not feasible for surgical resection;
- Has not received previous systemic antitumor drug therapy for metastatic/recurrent solid tumors;
- For people who have previously received neoadjuvant/adjuvant therapy, it takes more than 6 months from the last treatment to relapse or progression;
You likely can't join if
- Received the following treatment within 4 weeks before treatment: radiotherapy of tumor, major surgical operation or wound has not been completely...
- those who have contraindications to Miraberon: those who are allergic to Miraberon or any of its excipients;
- Active malignant tumors in the past 3 years, except for tumors participating in the study and local tumors that have been cured, such as skin basal...
- symptomatic brain or meningeal metastases; Severe infection (such as intravenous infusion of antibiotics, antifungals, or antivirals) within 4 weeks...
- have high blood pressure that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥ 150 mmHg or diastolic blood...
- Within 3 months before treatment, there were obvious clinical bleeding symptoms or obvious bleeding tendency (bleeding\> 30 mL within 3 months...
See the full eligibility criteria
- Patients voluntarily participate in the study, sign informed consent, and have good compliance;
- 18-65 years old (including 18 and 65 years old);
- solid tumors confirmed by histology and/or cytology, and advanced metastatic tumors that are not feasible for surgical resection;
- Has not received previous systemic antitumor drug therapy for metastatic/recurrent solid tumors;
- For people who have previously received neoadjuvant/adjuvant therapy, it takes more than 6 months from the last treatment to relapse or progression;
- Recovery of previous treatment-related AEs to National Cancer Institute Terminology Criteria for Common Adverse Events (NCI-CTCAE)≤ Grade 1 (excluding alopecia);
- According to RECIST 1.1 standard, there is at least one measurable lesion assessed by the research center, and the measurable lesion should be a lesion that has not received local treatment such as radiotherapy (the...
- ECOG physical condition: 0-1;
- Expected survival ≥ 12 weeks;
- 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...
- Received the following treatment within 4 weeks before treatment: radiotherapy of tumor, major surgical operation or wound has not been completely healed, β3 adrenoceptor agonist and corresponding clinical research...
- those who have contraindications to Miraberon: those who are allergic to Miraberon or any of its excipients;
- Active malignant tumors in the past 3 years, except for tumors participating in the study and local tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder...
- symptomatic brain or meningeal metastases; Severe infection (such as intravenous infusion of antibiotics, antifungals, or antivirals) within 4 weeks before treatment, or fever of unknown origin\> 38.5°C during...
- have high blood pressure that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Within 3 months before treatment, there were obvious clinical bleeding symptoms or obvious bleeding tendency (bleeding\> 30 mL within 3 months, hematemesis, black stool, hematochezia), hemoptysis (fresh blood\> 5 mL...
- The tumor is found to invade large vascular structures during screening, such as pulmonary artery, superior vena cava or inferior vena cava, and the researchers judge that there is a greater risk of bleeding;
- Active heart disease, including myocardial infarction, severe/unstable angina pectoris, 6 months before treatment. Echocardiography left ventricular ejection fraction \<50%, arrhythmia poorly controlled;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring frequent drainage after appropriate intervention;
- Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis...
- received treatment with live attenuated vaccine within 28 days prior to the first administration of the study drug;
- The patient has a known history of psychotropic substance abuse, alcohol abuse or drug abuse; a history of definite neurological or psychiatric disorders, including epilepsy or dementia
- tuberculosis infection history;
- known human immunodeficiency virus (HIV) infection;
- Known history of clinically significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV) carriers must exclude active HBV infection, I .e., HBV DNA positive (\>1 × 104 copies/mL or\> 2000 IU/mL);
- Known hepatitis C virus infection (HCV) and HCV RNA positive (\>1 x 103 copies/mL), or other hepatitis, cirrhosis];
- Patients with renal injury: GFR\<30 mL/min 1.73m2 or patients requiring hemodialysis
- any other medical condition, clinically significant metabolic, physical, or laboratory abnormality, which, in the investigator's judgment, would reasonably suspect that the patient has a disease or condition that is not...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.