Not yet recruiting NCT06221072
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JMT103, zoledronic acid.
- Who it may be relevant to
- Registry conditions: Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase III, Multicenter, Randomized, Double-blind Clinical Trail to Assess JMT103 Compared to Azoledronic Acid for the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors
Overview
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
- Drug JMT103
120 mg by subcutaneous injection every 4 weeks - Drug zoledronic acid
4 mg by intravenous drip (100mL:4mg) every 4 weeks
Primary outcome measures
- Time to the First on-study Skeletal-Related Event (SRE) [Time frame: Up to approximately 48 months]
Secondary outcome measures (7)
- Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE) [Time frame: Up to approximately 48 months]
- Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr) [Time frame: Up to approximately 28 months]
- Quality of life score (concise pain assessment Scale and EQ-5D-5L scale); [Time frame: Up to approximately 48 months]
- Incidence and severity of adverse events (AEs) [Time frame: Up to approximately 48 months]
- JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab) [Time frame: Up to approximately 48 months]
- Serum concentration of JMT103 [Time frame: Up to approximately 48 months]
- Overall survival (OS) [Time frame: Up to approximately 6 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06221072 · JMT103-012