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

ConditionGiant Cell Tumor of Bone
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorShanghai JMT-Bio Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: NarlumosbartExperimental treatment 1 intervention
Group B: DenosumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Patients With Giant Cell Objective Tumor Response

Time frame
From enrollment until 12 weeks

Secondary outcomes

1

Percentage of Patients With Giant Cell Objective Tumor Response

Time frame
Throughout the study period, up to approximately 4 years
2

Disease Control Rate (DCR)

Time frame
Up to approximately 4 years
3

Time to Response (TTR)

Time frame
Up to approximately 4 years
4

Duration of Response (DOR)

Time frame
Up to approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai JMT-Bio Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: