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

Primary Purpose

Giant Cell Tumor of Bone

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Narlumosbart
Denosumab
Sponsored by
Shanghai JMT-Bio Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Giant Cell Tumor of Bone focused on measuring Giant Cell Tumor of Bone

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Beijing Ji Shui Tan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Narlumosbart

Denosumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Patients With Giant Cell Objective Tumor Response

Secondary Outcome Measures

Percentage of Patients With Giant Cell Objective Tumor Response
Disease Control Rate (DCR)
Time to Response (TTR)
Duration of Response (DOR)
Time to Progression (TTP)
Percentage of Patients Downstaging the Planned Surgical Procedure
Time to First Tumor Surgery
Changes in Brief Pain Inventory Short Form (BPI-SF) score
Types and Proportion of Key Adverse Reactions
Serum JMT103 Concentrations
Number of Patients with Anti-JMT103 Antibodies

Full Information

First Posted
April 3, 2023
Last Updated
April 16, 2023
Sponsor
Shanghai JMT-Bio Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05813665
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai JMT-Bio Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Tumor of Bone
Keywords
Giant Cell Tumor of Bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Information Group Officer
Phone
+86-0311-69085587
Email
ctr-contact@mail.ecspc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohui Niu, B.M.
Organizational Affiliation
Beijing Ji Shui Tan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ji Shui Tan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohui Niu, B.M.
Phone
+86-010-58516506
Email
niuxiaohui@263.net

12. IPD Sharing Statement

Plan to Share IPD
No

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

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