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NCT Number: NCT07028268

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Li Zhang

PRINCIPAL_INVESTIGATOR

Yuanyuan Zhao

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR-2017、Denosumab placebo

Drug

SHR-2017; high dose ;Denosumab placebo

Denosumab;SHR-2017 placebo

Drug

Denosumab;SHR-2017 placebo

Primary outcomes

  1. Time to pain relief

    Time frame: randomization to 48 weeks after administration

    Analgesic evaluation using NRS scores

  2. 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 outcomes

  1. 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

  2. Change from Baseline in the daily average pain intensity in the index bonemetastasis cancer pain site.

    Time frame: randomization to 48 weeks after administration

  3. Change from Baseline in the daily worst pain intensity in the index bonemetastasis cancer pain site.

    Time frame: randomization to 48 weeks after administration

  4. 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

  5. Average daily total opioid consumption (in mg of morphine equivalent doses)

    Time frame: randomization to 48 weeks after administration

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jun 19, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.