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Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors

NCT04630522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2023-11-09

No results posted yet for this study

Summary

This is a randomized, open-label, dose-finding, multi-centre, phase Ⅰb study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors.

Conditions

  • Bone Metastases From Solid Tumors

Interventions

DRUG

Drug: JMT103- 120 mg SC Q4W

JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 4-week cycle.

DRUG

Drug: JMT103- 120 mg SC Q8W

JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 8-week cycle.

DRUG

Drug: JMT103- 180 mg SC Q8W

JMT103 is administered subcutaneously at a dose of 180 mg on day 1 of each 8-week cycle.

DIETARY_SUPPLEMENT

Dietary Supplement: Calcium Dietary Supplement: Vitamin D

Calcium is given orally at a dose of 500 mg at least, once daily. Vitamin D is given orally at a dose of 400 IU at least, once daily.

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Jin Li, MD · Shanghai East Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • China

Study Locations

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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 NCT04630522 on ClinicalTrials.gov