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Trial Title:
A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone
NCT ID:
NCT05813665
Condition:
Giant Cell Tumor of Bone
Conditions: Official terms:
Giant Cell Tumors
Bone Neoplasms
Giant Cell Tumor of Bone
Denosumab
Conditions: Keywords:
Giant Cell Tumor of Bone
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Narlumosbart
Description:
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.
Arm group label:
Narlumosbart
Other name:
JMT103
Intervention type:
Drug
Intervention name:
Denosumab
Description:
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.
Arm group label:
Denosumab
Other name:
XGEVA
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Fully informed and signed informed consent;
2. Male or female adults aged ≥ 18 years or skeletally mature adolescents must weigh at
least 45 kg and ≥ 12 years of age;
3. Pathologically confirmed giant cell tumor of bone that is surgically unresectable or
for which the planned surgery is associated with functional compromise or morbidity;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Exclusion Criteria:
1. 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;
2. Known or suspected diagnosis of other giant cell-rich tumors, brown cell tumor of
bone, or Paget's disease;
3. Known diagnosis of malignancy within the past 5 years, except for definitively
treated superficial basal cell carcinoma or cervical carcinoma in situ;
4. Bone metabolic disease including hypo-/hyperparathyroidism, hypo-/hyperthyroidism
(except for no need treatment subclinical hypothyroidism), hypopituitarism,
hyperprolactinemia, Cushing's syndrome, acromegaly, etc.;
5. Active infections requiring systematic treatment within 7 days prior to
randomization;
6. Known human immunodeficiency virus (HIV), syphilis infections or viral hepatitis;
7. Current receiving other anti-tumor therapy (such as radiation, chemotherapy, or
embolization, etc.);
8. Concurrent bisphosphonate treatment;
9. 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;
10. Known allergic/hypersensitive reaction to JMT103, positive control drug, calcium and
vitamin D;
11. 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.
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Ji Shui Tan Hospital
Address:
City:
Beijing
Zip:
100035
Country:
China
Contact:
Last name:
Xiaohui Niu, B.M.
Phone:
+86-010-58516506
Email:
niuxiaohui@263.net
Start date:
April 2023
Completion date:
September 2028
Lead sponsor:
Agency:
Shanghai JMT-Bio Inc.
Agency class:
Industry
Source:
Shanghai JMT-Bio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05813665
