drugset / Trial / NCT05813665

A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone

NCT05813665

Phase 3 Not yet recruiting 146 enrolled Shanghai JMT-Bio Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a phase Ⅲ, multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of narlumosbart (JMT103) in patients with unresectable or surgically difficult giant cell tumor of bone (GCTB). This clinical trial study hypothesizes narlumosbart administration groups are not inferior to active control administration groups.

Timeline

Start
2023-04
Primary completion
2028-06
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Denosumab Monoclonal antibody 120 mg Subcutaneous
Subject Narlumosbart Monoclonal antibody 120 mg Subcutaneous

Indications