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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
146
Administered by subcutaneous injection. Dietary Supplement: Calcium/Vitamin D. All patients should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.
Administered by subcutaneous injection. Dietary Supplement: Calcium/Vitamin D. All patients should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.
Beijing Ji Shui Tan Hospital
Beijing, Beijing Municipality, China
Percentage of Patients With Giant Cell Objective Tumor Response
Time frame: From enrollment until 12 weeks
Percentage of Patients With Giant Cell Objective Tumor Response
Time frame: Throughout the study period, up to approximately 4 years
Disease Control Rate (DCR)
Time frame: Up to approximately 4 years
Time to Response (TTR)
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
Time to Progression (TTP)
Time frame: Up to approximately 4 years
Percentage of Patients Downstaging the Planned Surgical Procedure
Time frame: From enrollment until surgery, up to approximately 4 years
Time to First Tumor Surgery
Time frame: From enrollment until the first tumor surgery, up to approximately 4 years
Changes in Brief Pain Inventory Short Form (BPI-SF) score
Time frame: From enrollment until the last dose, up to approximately 4 years
Types and Proportion of Key Adverse Reactions
Time frame: From the first dose of study drug until 90 days after the last dose, up to approximately 4 years
Serum JMT103 Concentrations
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Time frame: Days 8 of Cycle 1, Day 1 of Cycle 2, 3, 4, 5, 6, and 90 days after the last dose (each cycle is 28 days)
Number of Patients with Anti-JMT103 Antibodies
Time frame: Day 1 of Cycle 1, 2, 4, 6, and 90 days after the last dose (each cycle is 28 days)