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

NCT06221072
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Phase
Phase 3
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Recruitment status
Not yet recruiting
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Participants
1,360
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Lead sponsor
Shanghai JMT-Bio Inc.
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Start date
2024-04-05
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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.
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Short 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
clinicaltrials.gov
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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-05-31
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First posted
2024-01-24
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Registry last updated
2024-01-24
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Primary completion date
2027-05-31
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Start date
2024-04-05
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Participants
1,360
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Participant count basis
Estimated
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Planned participants
1,360
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Protocol amendments
0
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Shanghai JMT-Bio Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06221072
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ClinicalTrials.gov ID
NCT06221072
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Double-blind
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to the First on-study Skeletal-Related Event (SRE)

    Timeframe: Up to approximately 48 months

  1. Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE)

    Timeframe: Up to approximately 48 months

  2. Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr)

    Timeframe: Up to approximately 28 months

  3. Quality of life score (concise pain assessment Scale and EQ-5D-5L scale);

    Timeframe: Up to approximately 48 months

  4. Incidence and severity of adverse events (AEs)

    Timeframe: Up to approximately 48 months

  5. JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab)

    Timeframe: Up to approximately 48 months

  6. Serum concentration of JMT103

    Timeframe: Up to approximately 48 months

  7. Overall survival (OS)

    Timeframe: Up to approximately 6 years

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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.).
Sources for eligibility
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)