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 | Not Yet Recruiting Phase 3

• 1 other identifier: JMT103-012
• Study Type: interventional
• Target: 1,360
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors

Outcome Measures

Primary Outcomes (1)

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

  Up to approximately 48 months

Secondary Outcomes (7)

• 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

Study Arms (2)

Group 1-JMT103

EXPERIMENTAL

Participants will receive JMT103 and zoledronic acid placebo.

Drug: JMT103

Group 2-zoledronic acid

EXPERIMENTAL

Participants will receive zoledronic acid and JMT103 placebo.

Drug: zoledronic acid

Interventions

JMT103 DRUG

120 mg by subcutaneous injection every 4 weeks

Group 1-JMT103

zoledronic acid DRUG

4 mg by intravenous drip (100mL:4mg) every 4 weeks

Group 2-zoledronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Zefei Jiang, M.D

CONTACT

13901372170; jzf_cscobc@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter, randomized, double-blind clinical Trail

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 24, 2024
• Study Start: April 5, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share