What is milaberon studying for advanced solid tumors?

Milaberon is being studied in combination with standard cancer treatments to evaluate its safety and effectiveness in adults with advanced solid tumors that cannot be surgically removed. The study, sponsored by Zhejiang Provincial People's Hospital, aims to better understand how milaberon works alongside existing therapies and monitors potential side effects such as urinary tract infections and heart-related issues.

Who may be eligible for this advanced solid tumor clinical trial?

Adults aged 18 to 65 years with confirmed advanced solid tumors not suitable for surgery may be eligible. Participants should not have received prior systemic treatment for metastatic or recurrent tumors and must have good physical health and organ function. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 18Years - 65Years

All Genders

ID06534762

Safety and Effectiveness of Milaberon Combined With Standard Treatment for Adults With Advanced Solid Tumors

Led by Zhejiang Provincial People's Hospital · Updated on 2024-08-02

260

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the use of milaberon, combined with standard treatments, in adults with advanced solid tumors that cannot be removed surgically. The study focuses on evaluating the safety and effectiveness of a higher dose of mirabegron 100mgday, which is above the usual clinical dose, with particular attention to urinary tract infections and heart-related side effects. This is an open, multicenter clinical study sponsored by Zhejiang Provincial Peoples Hospital. Participants receive 100mg of mirabegron orally once daily in the morning until their disease progresses. If severe side effects grade 3 or higher related to mirabegron occur, dosing is paused until symptoms improve to grade 2 or lower, then resumed at half the dose dose increases are not allowed. If recovery criteria are not met within 28 days, the drug is permanently stopped. The study includes various cohorts with different cancer types receiving standard chemotherapy or immunotherapy regimens alongside the investigational drug. During the study, participants will undergo regular evaluations including blood tests, urine analysis, heart monitoring, and physical exams to assess treatment effects and side effects. Researchers will measure outcomes such as overall response rate and dose-limiting toxicities over three years. Participants are monitored for disease control, survival, and progression. The study duration varies with ongoing assessments until disease progression or unacceptable toxicity occurs.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients voluntarily participate in the study, sign informed consent, and have good compliance
Aged between 18 and 65 years inclusive
Solid tumors confirmed by histology or cytology, with advanced metastatic tumors not suitable for surgery
No previous systemic antitumor drug therapy for metastatic or recurrent solid tumors
More than 6 months since last neoadjuvant or adjuvant therapy if previously treated
Recovery from prior treatment-related adverse events to grade 1 or lower (excluding alopecia)
At least one measurable lesion by RECIST 1.1 not previously treated locally
ECOG physical condition score of 0 or 1
Expected survival of at least 12 weeks
Normal major organ function including blood, liver, kidney, coagulation, and thyroid function
Women of childbearing age must have negative pregnancy test and agree to use effective contraception during and 3 months after study

You will not qualify if you...

Treatment within 4 weeks before study with tumor radiotherapy, major surgery not fully healed, or beta-3 adrenoceptor agonists
Allergy or contraindication to mirabegron or its excipients
Active malignant tumors in past 3 years except cured local tumors
Symptomatic brain or meningeal metastases
Severe infection or fever above 38.5°C during screening
Uncontrolled high blood pressure (≥150/100 mmHg)
Recent significant bleeding events or clotting disorders
Tumor invading large blood vessels with high bleeding risk
Active heart disease or poorly controlled arrhythmia
Uncontrollable pleural, pericardial effusion, or ascites
Active autoimmune disease or history requiring systemic treatment
Live attenuated vaccine within 28 days before treatment
History of substance abuse or significant psychiatric disorders
Tuberculosis infection history
Known HIV infection
Significant liver disease or viral hepatitis with active infection
Severe renal impairment or requiring dialysis
Other medical conditions judged unsuitable by investigators

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Until disease progression or discontinuation

Participants receive milaberon 100mg orally once daily in the morning combined with standard therapy for advanced solid tumors until disease progression or unacceptable toxicity occurs.

Visits every 3 weeks during chemotherapy cycles; frequency may vary depending on the standard therapy regimen