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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Narlumosbart
  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.
• Препарат Denosumab
  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.

Первичные конечные точки

• Percentage of Patients With Giant Cell Objective Tumor Response [Срок оценки: From enrollment until 12 weeks]

Вторичные конечные точки (11)

• Percentage of Patients With Giant Cell Objective Tumor Response [Срок оценки: Throughout the study period, up to approximately 4 years]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 4 years]
• Time to Response (TTR) [Срок оценки: Up to approximately 4 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 4 years]
• Time to Progression (TTP) [Срок оценки: Up to approximately 4 years]
• Percentage of Patients Downstaging the Planned Surgical Procedure [Срок оценки: From enrollment until surgery, up to approximately 4 years]
• Time to First Tumor Surgery [Срок оценки: From enrollment until the first tumor surgery, up to approximately 4 years]
• Changes in Brief Pain Inventory Short Form (BPI-SF) score [Срок оценки: From enrollment until the last dose, up to approximately 4 years]
• Types and Proportion of Key Adverse Reactions [Срок оценки: From the first dose of study drug until 90 days after the last dose, up to approximately 4 years]
• Serum JMT103 Concentrations [Срок оценки: 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 [Срок оценки: Day 1 of Cycle 1, 2, 4, 6, and 90 days after the last dose (each cycle is 28 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Ji Shui Tan Hospital — Пекин

Идентификаторы

NCT: NCT05813665 · JMT103-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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