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Giant Cell Tumor of BonePhase 3NCT05813665

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

A Phase 3 study testing Narlumosbart and Denosumab in people with Giant Cell Tumor of Bone, run by Shanghai JMT-Bio Inc. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Giant Cell Tumor of Bone
What is being tested?
Narlumosbart and Denosumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteChina
Study dates
Apr 2023to Sep 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group Officer contact

+86-0311-69085587

ctr-contact@mail.ecspc.com

China1 site

  • Beijing Ji Shui Tan Hospital

    Beijing, Beijing Municipality, 100035

    Xiaohui Niu, B.M., +86-010-58516506, niuxiaohui@263.net

Other trials in China

About this study

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

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.

Being tested
Narlumosbart, Denosumab
Keywords
Giant Cell Tumor of Bone
Medical subject headings
Giant Cell Tumor of Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NarlumosbartDrug

    Also called JMT103

    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.

  • DenosumabDrug

    Also called XGEVA

    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.

Study groups in NCT05813665
Study groupRoleWhat they receive
NarlumosbartExperimentalPatients 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.
Receives: Drug: Narlumosbart
DenosumabActive comparatorPatients 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.
Receives: Drug: Denosumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With Giant Cell Objective Tumor Response

    Measured: From enrollment until 12 weeks

Secondary outcomes (11)

  1. Percentage of Patients With Giant Cell Objective Tumor Response

    Measured: Throughout the study period, up to approximately 4 years

  2. Disease Control Rate (DCR)

    Measured: Up to approximately 4 years

  3. Time to Response (TTR)

    Measured: Up to approximately 4 years

  4. Duration of Response (DOR)

    Measured: Up to approximately 4 years

  5. Time to Progression (TTP)

    Measured: Up to approximately 4 years

  6. Percentage of Patients Downstaging the Planned Surgical Procedure

    Measured: From enrollment until surgery, up to approximately 4 years

  7. Time to First Tumor Surgery

    Measured: From enrollment until the first tumor surgery, up to approximately 4 years

  8. Changes in Brief Pain Inventory Short Form (BPI-SF) score

    Measured: From enrollment until the last dose, up to approximately 4 years

  9. Types and Proportion of Key Adverse Reactions

    Measured: From the first dose of study drug until 90 days after the last dose, up to approximately 4 years

  10. Serum JMT103 Concentrations

    Measured: 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)

  11. Number of Patients with Anti-JMT103 Antibodies

    Measured: Day 1 of Cycle 1, 2, 4, 6, and 90 days after the last dose (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2023
  2. Study startApr 2023 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05813665
Sponsor's protocol ID
JMT103-011
Status last verified
Apr 2023
First submitted
3 Apr 2023
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Narlumosbart and Denosumab in people with Giant Cell Tumor of Bone, run by Shanghai JMT-Bio Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group Officer (+86-0311-69085587, ctr-contact@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Giant Cell Objective Tumor Response (time frame: From enrollment until 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05813665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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