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

NCT05813665 | Not Yet Recruiting Phase 3

• 1 other identifier: JMT103-011
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Keywords

Giant Cell Tumor of Bone

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Giant Cell Objective Tumor Response

  From enrollment until 12 weeks

Secondary Outcomes (11)

• Percentage of Patients With Giant Cell Objective Tumor Response

  Throughout the study period, up to approximately 4 years

• Disease Control Rate (DCR)

  Up to approximately 4 years

• Time to Response (TTR)

  Up to approximately 4 years

• Duration of Response (DOR)

  Up to approximately 4 years

• Time to Progression (TTP)

  Up to approximately 4 years

Study Arms (2)

Narlumosbart

EXPERIMENTAL

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.

Drug: Narlumosbart

Denosumab

ACTIVE COMPARATOR

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.

Drug: Denosumab

Interventions

Narlumosbart 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.

Also known as: JMT103

Narlumosbart

Denosumab 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.

Also known as: XGEVA

Denosumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

Beijing Ji Shui Tan Hospital

Beijing, Beijing Municipality, 100035, China

Location

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaohui Niu, B.M.

  Beijing Ji Shui Tan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group Officer

CONTACT

+86-0311-69085587; ctr-contact@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)