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This is a phase â…¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Giant Cell Objective Tumor Response | From enrollment until 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group Officer | Contact | +86-0311-69085587 | ctr-contact@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohui Niu, B.M. | Beijing Ji Shui Tan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ji Shui Tan Hospital | Beijing | Beijing Municipality | 100035 | China |
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| ID | Term |
|---|---|
| D018212 | Giant Cell Tumor of Bone |
| ID | Term |
|---|---|
| D005870 | Giant Cell Tumors |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| 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. |
|
|
| 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 |
| Percentage of Patients Downstaging the Planned Surgical Procedure | From enrollment until surgery, up to approximately 4 years |
| Time to First Tumor Surgery | From enrollment until the first tumor surgery, up to approximately 4 years |
| Changes in Brief Pain Inventory Short Form (BPI-SF) score | From enrollment until the last dose, up to approximately 4 years |
| 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 |
| 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) |
| 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) |
| D009369 | Neoplasms |
| D018213 | Neoplasms, Bone Tissue |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |