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

Giant Cell Tumor of Bone Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05813665
• Other study ID #: JMT103-011
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2023
• Est. completion date: September 2028

Study information

• Verified date: April 2023
• Source: Shanghai JMT-Bio Inc.
• Contact: Clinical Trials Information Group Officer
• Phone: +86-0311-69085587
• Email: ctr-contact[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 146
• Est. completion date: September 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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-?B 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.

Related Conditions & MeSH terms

• Bone Neoplasms
• Giant Cell Tumor of Bone
• Giant Cell Tumors

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Ji Shui Tan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai JMT-Bio Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Giant Cell Objective Tumor Response		From enrollment until 12 weeks
Secondary	Percentage of Patients With Giant Cell Objective Tumor Response		Throughout the study period, up to approximately 4 years
Secondary	Disease Control Rate (DCR)		Up to approximately 4 years
Secondary	Time to Response (TTR)		Up to approximately 4 years
Secondary	Duration of Response (DOR)		Up to approximately 4 years
Secondary	Time to Progression (TTP)		Up to approximately 4 years
Secondary	Percentage of Patients Downstaging the Planned Surgical Procedure		From enrollment until surgery, up to approximately 4 years
Secondary	Time to First Tumor Surgery		From enrollment until the first tumor surgery, up to approximately 4 years
Secondary	Changes in Brief Pain Inventory Short Form (BPI-SF) score		From enrollment until the last dose, up to approximately 4 years
Secondary	Types and Proportion of Key Adverse Reactions		From the first dose of study drug until 90 days after the last dose, up to approximately 4 years
Secondary	Serum JMT103 Concentrations		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)
Secondary	Number of Patients with Anti-JMT103 Antibodies		Day 1 of Cycle 1, 2, 4, 6, and 90 days after the last dose (each cycle is 28 days)