A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors

Официальное название

A Multicenter, Randomized, Double-Blind, Positively Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors

Обзор

The study is being conducted to evaluate the efficacy, and safety of SHR-2017 Injection in Patients with Bone Metastases from Solid Tumors. To explore the reasonable dosage of SHR-2017 Injection for Bone Metastases from Solid Tumors

Вмешательства

• Препарат SHR-2017、Denosumab placebo
  SHR-2017; high dose ；Denosumab placebo
• Препарат SHR-2017、Denosumab placebo
  SHR-2017; low dose ；Denosumab placebo
• Препарат Denosumab；SHR-2017 placebo
  Denosumab；SHR-2017 placebo

Первичные конечные точки

• Time to pain relief [Срок оценки: randomization to 48 weeks after administration]
• percentage of change in the bone turnover marker urine N-telopeptide corrected for urine creatinine (uNTx/Cr) from baseline to study week 13 [Срок оценки: randomization to 13 weeks after administration]

Вторичные конечные точки (5)

• Time to first on-study SRE (defined as pathologic fracture, radiation or surgery to bone, or spinalcord compression). [Срок оценки: randomization to 72 weeks after administration]
• Change from Baseline in the daily average pain intensity in the index bonemetastasis cancer pain site. [Срок оценки: randomization to 48 weeks after administration]
• Change from Baseline in the daily worst pain intensity in the index bonemetastasis cancer pain site. [Срок оценки: randomization to 48 weeks after administration]
• Response as defined by a ≥2 point reduction from Baseline in the daily average and daily worst pain intensity NRS score in the index bone metastasis cancer pain site [Срок оценки: randomization to 48 weeks after administration]
• Average daily total opioid consumption (in mg of morphine equivalent doses) [Срок оценки: randomization to 48 weeks after administration]

Критерии участия

Критерии включения

• Able and willing to provide a written informed consent；
• Male or female, ≥18 years of age；
• Histologically or cytologically confirmed solid tumors；
• At least 1 bone metastasis demonstrated by radiologic imaging or histopathology；
• Eastern Cooperative Oncology Group performance Status≤2。
• Life expectancy was judged by the investigators to be at least 6 months;
• Adequate organ function at Screening
• Female subjects with a negative blood pregnancy test and are not breastfeeding

Критерии исключения

• Pre-existing or comorbid related oral diseases or oral cavity requiring surgery, etc；
• History of major joint (e.g., hip, knee, or shoulder) trauma or surgery prior to the first dose of the drug；
• Received radiotherapeutic drugs or bone radiotherapy prior to the first study drug administration
• Any cardiovascular disease for which the investigator considers the subject unfit to participate in the study
• resting tachycardia or resting bradycardia;
• The subject's pain is predominantly from pain unrelated to the bone metastases;
• Subject is unable to perform a pain assessment;
• Symptomatic or treatment-requiring brain metastases or other central nervous system metastases
• Comorbid infectious disease
• Prior receipt of exogenous nerve growth factor or anti-nerve growth factor antibodies;
• Prior history of allergy to relevant drug ingredients or components;
• Participation in other clinical trials within a certain period of time
• Subjects who, in the opinion of the investigator, have any other factors

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07028268 · SHR-2017-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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