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

Shanghai JMT-Bio Inc.0 sites1,360 target enrollmentApril 5, 2024

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

InterventionsJMT103 zoledronic acid

DrugsJMT103 zoledronic acid

Overview

Phase: Phase 3
Intervention: JMT103
Conditions: Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
Sponsor: Shanghai JMT-Bio Inc.
Enrollment: 1360
Primary Endpoint: Time to the First on-study Skeletal-Related Event (SRE)
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 5, 2024

End Date

May 31, 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai JMT-Bio Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.).

Arms & Interventions

Group 1-JMT103

Participants will receive JMT103 and zoledronic acid placebo.

Intervention: JMT103

Group 2-zoledronic acid

Participants will receive zoledronic acid and JMT103 placebo.

Intervention: zoledronic acid

Outcomes

Primary Outcomes

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

Time Frame: Up to approximately 48 months

Secondary Outcomes

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)