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

S

Shanghai JMT-Bio

Status and phase

Not yet enrolling
Phase 3

Conditions

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

Treatments

Drug: JMT103
Drug: zoledronic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT06221072
JMT103-012

Details and patient eligibility

About

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.

Enrollment

1,360 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,360 participants in 2 patient groups

Group 1-JMT103
Experimental group
Description:
Participants will receive JMT103 and zoledronic acid placebo.
Treatment:
Drug: JMT103
Group 2-zoledronic acid
Experimental group
Description:
Participants will receive zoledronic acid and JMT103 placebo.
Treatment:
Drug: zoledronic acid

Trial contacts and locations

0

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Central trial contact

Clinical Trials Information Group officer; Zefei Jiang, M.D

Data sourced from clinicaltrials.gov

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