Recruiting NCT07028268
A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-2017、Denosumab placebo, SHR-2017、Denosumab placebo, Denosumab；SHR-2017 placebo.
- Who it may be relevant to
- Registry conditions: For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug SHR-2017、Denosumab placebo
SHR-2017; high dose ；Denosumab placebo - Drug SHR-2017、Denosumab placebo
SHR-2017; low dose ；Denosumab placebo - Drug Denosumab；SHR-2017 placebo
Denosumab；SHR-2017 placebo
Primary outcome measures
- Time to pain relief [Time frame: 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 [Time frame: randomization to 13 weeks after administration]
Secondary outcome measures (5)
- Time to first on-study SRE (defined as pathologic fracture, radiation or surgery to bone, or spinalcord compression). [Time frame: randomization to 72 weeks after administration]
- Change from Baseline in the daily average pain intensity in the index bonemetastasis cancer pain site. [Time frame: randomization to 48 weeks after administration]
- Change from Baseline in the daily worst pain intensity in the index bonemetastasis cancer pain site. [Time frame: 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 [Time frame: randomization to 48 weeks after administration]
- Average daily total opioid consumption (in mg of morphine equivalent doses) [Time frame: randomization to 48 weeks after administration]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07028268 · SHR-2017-201