For Prevention of Bone Events in Patients With Bone Metastases From Solid TumorsPhase 2NCT07028268
A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors
A Phase 2 study of For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2025to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang
Yuanyuan Zhao
About this study
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
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
- Being tested
- SHR-2017、Denosumab placebo, Denosumab；SHR-2017 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2017、Denosumab placeboDrug
SHR-2017; high dose ；Denosumab placebo
SHR-2017、Denosumab placeboDrug
SHR-2017; low dose ；Denosumab placebo
Denosumab；SHR-2017 placeboDrug
Denosumab；SHR-2017 placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR-2017、Denosumab placebo | Experimental | Not described Receives: Drug: SHR-2017、Denosumab placebo |
| Treatment group B: SHR-2017、Denosumab placebo | Experimental | Not described Receives: Drug: SHR-2017、Denosumab placebo |
| Treatment group C: Denosumab；SHR-2017 placebo | Active comparator | Not described Receives: Drug: Denosumab；SHR-2017 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to pain relief
Analgesic evaluation using NRS scores
Measured: 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
Measured: randomization to 13 weeks after administration
Secondary outcomes (5)
Time to first on-study SRE (defined as pathologic fracture, radiation or surgery to bone, or spinalcord compression).
Measured: randomization to 72 weeks after administration
Change from Baseline in the daily average pain intensity in the index bonemetastasis cancer pain site.
Measured: randomization to 48 weeks after administration
Change from Baseline in the daily worst pain intensity in the index bonemetastasis cancer pain site.
Measured: 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
Measured: randomization to 48 weeks after administration
Average daily total opioid consumption (in mg of morphine equivalent doses)
Measured: randomization to 48 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start24 Jun 2025
- Primary completionDec 2025 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for For Prevention of Bone Events in Patients With Bone Metastases From Solid TumorsStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028268
- Sponsor's protocol ID
- SHR-2017-201
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07028268
- Acronym / sponsor ID
- SHR-2017-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: SHR-2017、Denosumab placebo | Experimental | Drug: SHR-2017、Denosumab placebo |
| Treatment group B: SHR-2017、Denosumab placebo | Experimental | Drug: SHR-2017、Denosumab placebo |
| Treatment group C: Denosumab；SHR-2017 placebo | Active comparator | Drug: Denosumab；SHR-2017 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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。
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2017、Denosumab placeboSHR-2017; high dose ；Denosumab placebo | Drug | Treatment group A: SHR-2017、Denosumab placebo |
| SHR-2017、Denosumab placeboSHR-2017; low dose ；Denosumab placebo | Drug | Treatment group B: SHR-2017、Denosumab placebo |
| Denosumab；SHR-2017 placeboDenosumab；SHR-2017 placebo | Drug | Treatment group C: Denosumab；SHR-2017 placebo |
Primary outcome
Time to pain relief
Time frame: randomization to 48 weeks after administration
Analgesic evaluation using NRS scores
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors
Not yet recruitingPhase 3
A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid
Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Zhao (+0518-82342973, qian.zhao@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to pain relief (time frame: randomization to 48 weeks after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.