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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
• Intervention / Treatment: Drug: JMT103; Drug: zoledronic acid

• Study Type: Interventional
• Enrollment (Estimated): 1360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn
• Study Contact Backup: Name: Zefei Jiang, M.D; Phone Number: 13901372170; Email: jzf_cscobc@csco.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1-JMT103; Participants will receive JMT103 and zoledronic acid placebo.	Drug: JMT103; 120 mg by subcutaneous injection every 4 weeks
Experimental: Group 2-zoledronic acid; Participants will receive zoledronic acid and JMT103 placebo.	Drug: zoledronic acid; 4 mg by intravenous drip (100mL:4mg) every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to the First on-study Skeletal-Related Event (SRE)	Up to approximately 48 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai JMT-Bio Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases; Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: JMT103-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No