Not yet recruiting NCT05813665
A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Narlumosbart, Denosumab.
- Who it may be relevant to
- Registry conditions: Giant Cell Tumor of Bone. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Randomized, Double-blind, Active-controlled, Phase Ⅲ Study to Evaluate Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone
Overview
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.
Interventions
- Drug Narlumosbart
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. - Drug Denosumab
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.
Primary outcome measures
- Percentage of Patients With Giant Cell Objective Tumor Response [Time frame: From enrollment until 12 weeks]
Secondary outcome measures (11)
- 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 [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)]
Eligibility criteria
Inclusion criteria
- Fully informed and signed informed consent;
- Male or female adults aged ≥ 18 years or skeletally mature adolescents must weigh at least 45 kg and ≥ 12 years of age;
- Pathologically confirmed giant cell tumor of bone that is surgically unresectable or for which the planned surgery is associated with functional compromise or morbidity;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Exclusion criteria
- Previous or ongoing osteomyelitis or osteonecrosis of the jaw, non-healed dental/oral surgery, active dental or jaw condition requiring oral surgery, planned invasive dental procedure during the study;
- Known or suspected diagnosis of other giant cell-rich tumors, brown cell tumor of bone, or Paget's disease;
- Known diagnosis of malignancy within the past 5 years, except for definitively treated superficial basal cell carcinoma or cervical carcinoma in situ;
- Bone metabolic disease including hypo-/hyperparathyroidism, hypo-/hyperthyroidism (except for no need treatment subclinical hypothyroidism), hypopituitarism, hyperprolactinemia, Cushing's syndrome, acromegaly, etc.;
- Active infections requiring systematic treatment within 7 days prior to randomization;
- Known human immunodeficiency virus (HIV), syphilis infections or viral hepatitis;
- Current receiving other anti-tumor therapy (such as radiation, chemotherapy, or embolization, etc.);
- Concurrent bisphosphonate treatment;
- Use of anti-receptor activator of nuclear factor-κB ligand (RANKL) antibody within six months prior to screening, or no response to previous RANKL antibody treatment;
- Known allergic/hypersensitive reaction to JMT103, positive control drug, calcium and vitamin D;
- Pregnant or lactating females; For those of child bearing potential, refusal to use effective contraception methods from signing informed consent to 6 months after last administration.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Ji Shui Tan Hospital — Beijing
Identifiers
NCT: NCT05813665 · JMT103-011