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

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2028-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1-JMT103

Participants will receive JMT103 and zoledronic acid placebo.

Group Type: EXPERIMENTAL

JMT103

Intervention Type: DRUG

120 mg by subcutaneous injection every 4 weeks

Group 2-zoledronic acid

Participants will receive zoledronic acid and JMT103 placebo.

Group Type: EXPERIMENTAL

zoledronic acid

Intervention Type: DRUG

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

Interventions

JMT103

120 mg by subcutaneous injection every 4 weeks

Intervention Type: DRUG

zoledronic acid

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

Intervention Type: DRUG

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai JMT-Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

86-0311-69085587

Zefei Jiang, M.D

Role: CONTACT

jzf_cscobc@csco.org.cn

13901372170

Other Identifiers

JMT103-012

Identifier Type: -

Identifier Source: org_study_id