Status:
NOT_YET_RECRUITING
A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid
Lead Sponsor:
Shanghai JMT-Bio Inc.
Conditions:
Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is...
Eligibility Criteria
Inclusion
- Age: older than 18 years;
- Breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone \<50 ng/dL or 1.7 nmol/L and serum PSA progression after surgery or drug castration treatment);
- Patients with imaging studies showing at least one tumor bone metastasis;
- With a good organ function;
- Expected survival of at least 6 months.
Exclusion
- Previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period;
- Radiotherapy or surgery for the bone metastases is planned during the study;
- Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI/CT examination to exclude patients with brain metastasis);
- Patients with bone metabolic diseases \[e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.\];
- Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP\> 150/90 mmHg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction \<50%;
- Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose;
- Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.).
Key Trial Info
Start Date :
April 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
1360 Patients enrolled
Trial Details
Trial ID
NCT06221072
Start Date
April 5 2024
End Date
May 31 2028
Last Update
January 24 2024
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