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

Phase 3

Not yet recruiting

• Conditions: Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
• Interventions: Drug: JMT103; Drug: zoledronic acid

• Registration Number: NCT06221072
• Lead Sponsor: Shanghai JMT-Bio Inc.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Study Start: 2024-04-05
• Primary Completion: 2027-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1360

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.

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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.).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1-JMT103	JMT103	Participants will receive JMT103 and zoledronic acid placebo.
Group 2-zoledronic acid	zoledronic acid	Participants will receive zoledronic acid and JMT103 placebo.

Primary Outcome Measures

Name	Time	Method
Time to the First on-study Skeletal-Related Event (SRE)	Up to approximately 48 months

Secondary Outcome Measures

Name	Time	Method
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
JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab)	Up to approximately 48 months
Serum concentration of JMT103	Up to approximately 48 months
Overall survival (OS)	Up to approximately 6 years