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

NCT ID: NCT05813665

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2028-09-30

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.

Conditions

Giant Cell Tumor of Bone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Narlumosbart

Patients will receive narlumosbart 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15 of the first cycle until one of the following occurred: complete tumor resection, disease progression, intolerable toxicity, decision by the patient to discontinue, or decision by the investigator that the patient could no longer benefit from the treatment.

Group Type: EXPERIMENTAL

Narlumosbart

Intervention Type: DRUG

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

Patients will receive denosumab 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15 of the first cycle until one of the following occurred: complete tumor resection, disease progression without clinical benefit, decision by the patient to discontinue, or decision by the investigator that the patient could no longer benefit from the treatment.

Group Type: ACTIVE_COMPARATOR

Denosumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

JMT103; XGEVA

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai JMT-Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaohui Niu, B.M.

Role: PRINCIPAL_INVESTIGATOR

Beijing Ji Shui Tan Hospital

Locations

Beijing Ji Shui Tan Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Clinical Trials Information Group Officer

Role: CONTACT

ctr-contact@mail.ecspc.com

+86-0311-69085587

Facility Contacts

Xiaohui Niu, B.M.

Role: primary

niuxiaohui@263.net

+86-010-58516506

Other Identifiers

JMT103-011

Identifier Type: -

Identifier Source: org_study_id