Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
Conditions
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 to determine if JMT103 is non-inferior to zoledronic acid.
Interventions
DRUGzoledronic acid
4 mg by intravenous drip (100mL:4mg) every 4 weeks
DRUGJMT103
120 mg by subcutaneous injection every 4 weeks
Sponsors
Shanghai JMT-Bio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
multicenter, randomized, double-blind clinical Trail
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: older than 18 years; 2. 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); 3. Patients with imaging studies showing at least one tumor bone metastasis; 4. With a good organ function; 5. Expected survival of at least 6 months.
Exclusion criteria
1. 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; 2. Radiotherapy or surgery for the bone metastases is planned during the study; 3. Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI/CT examination to exclude patients with brain metastasis); 4. Patients with bone metabolic diseases \[e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.\]; 5. 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%; 6. Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose; 7. Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the First on-study Skeletal-Related Event (SRE) | Up to approximately 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr) | Up to approximately 28 months |
| Quality of life score (concise pain assessment Scale and EQ-5D-5L scale); | Up to approximately 48 months |
| Incidence and severity of adverse events (AEs) | Up to approximately 48 months |
| Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE) | Up to approximately 48 months |
| Serum concentration of JMT103 | Up to approximately 48 months |
| Overall survival (OS) | Up to approximately 6 years |
| JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab) | Up to approximately 48 months |
Contacts
Primary ContactClinical Trials Information Group officer
Backup ContactZefei Jiang, M.D
Outcome results
None listed