To hear about similar clinical trials, please enter your email below
Trial Title:
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
NCT ID:
NCT06221072
Condition:
Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
Conditions: Official terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Zoledronic Acid
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
multicenter, randomized, double-blind clinical Trail
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Double-blind
Intervention:
Intervention type:
Drug
Intervention name:
JMT103
Description:
120 mg by subcutaneous injection every 4 weeks
Arm group label:
Group 1-JMT103
Intervention type:
Drug
Intervention name:
zoledronic acid
Description:
4 mg by intravenous drip (100mL:4mg) every 4 weeks
Arm group label:
Group 2-zoledronic acid
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.
Criteria for eligibility:
Criteria:
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.).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 5, 2024
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Shanghai JMT-Bio Inc.
Agency class:
Industry
Source:
Shanghai JMT-Bio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06221072
