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 — Phase 3, Not yet recruiting, 1360 participants, Shanghai JMT-Bio Inc.

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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

Registry	NCT06221072
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	1360 (Estimated)
Sponsor	Shanghai JMT-Bio Inc. (Industry)
Conditions	Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
Interventions	JMT103, zoledronic acid (Drug)
Dates	start 2024-04-05 (estimated), primary completion 2027-05-31 (estimated), completion 2028-05-31 (estimated), first posted 2024-01-24, last updated 2024-01-24

-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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+Arms and interventions

Arm	Type	Interventions	Description
Group 1-JMT103	Experimental	Drug: JMT103	Participants will receive JMT103 and zoledronic acid placebo.
Group 2-zoledronic acid	Experimental	Drug: zoledronic acid	Participants will receive zoledronic acid and JMT103 placebo.

JMT103 (Drug): 120 mg by subcutaneous injection every 4 weeks
zoledronic acid (Drug): 4 mg by intravenous drip (100mL:4mg) every 4 weeks

+Outcome measures

Primary outcomes

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

Secondary outcomes

Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE) [Up to approximately 48 months]
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]
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]

+Eligibility

Sex: All, ages: 18 Years to any

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.).