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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 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1360

Last updated 2024-01-24

No results posted yet for this study

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

Interventions

DRUG

JMT103

120 mg by subcutaneous injection every 4 weeks

DRUG

zoledronic acid

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

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2027-05-31
Completion
2028-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06221072 on ClinicalTrials.gov