Clinical trial NCT05813665: A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Giant Cell Tumor of Bone
Keywords: Giant Cell Tumor of Bone
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 146
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Percentage of Patients With Giant Cell Objective Tumor Response
timeFrame: From enrollment until 12 weeks
Secondary outcomes:
measure: Percentage of Patients With Giant Cell Objective Tumor Response
timeFrame: Throughout the study period, up to approximately 4 years
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 4 years
measure: Time to Response (TTR)
timeFrame: Up to approximately 4 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 4 years
measure: Time to Progression (TTP)
timeFrame: Up to approximately 4 years
measure: Percentage of Patients Downstaging the Planned Surgical Procedure
timeFrame: From enrollment until surgery, up to approximately 4 years
measure: Time to First Tumor Surgery
timeFrame: From enrollment until the first tumor surgery, up to approximately 4 years
measure: Changes in Brief Pain Inventory Short Form (BPI-SF) score
timeFrame: From enrollment until the last dose, up to approximately 4 years
measure: Types and Proportion of Key Adverse Reactions
timeFrame: From the first dose of study drug until 90 days after the last dose, up to approximately 4 years
measure: Serum JMT103 Concentrations
timeFrame: 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)
measure: Number of Patients with Anti-JMT103 Antibodies
timeFrame: Day 1 of Cycle 1, 2, 4, 6, and 90 days after the last dose (each cycle is 28 days)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ji Shui Tan Hospital
state: Beijing
Study officials:
affiliation: Beijing Ji Shui Tan Hospital
name: Xiaohui Niu, B.M.
role: PRINCIPAL_INVESTIGATOR
References: