New shot aims to stop bone breaks in cancer patients
NCT ID NCT07028268
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new injection called SHR-2017 in 210 adults with solid tumors that have spread to their bones. The goal is to see if it can prevent bone complications like fractures and pain, compared to an existing drug (denosumab). Participants will receive either high or low doses of SHR-2017 or denosumab, and researchers will monitor pain levels and bone health markers over several weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-2017 (a drug similar to denosumab, given as an injection)
- What this could lead to
- If successful, this could provide a new treatment option to prevent bone fractures and pain in people with cancer that has spread to their bones.
- What could go wrong
- This is an early Phase 2 trial with only 210 participants, so results may not confirm effectiveness. The drug may cause side effects similar to denosumab, such as low calcium levels or jaw problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able and willing to provide a written informed consent； 2. Male or female, ≥18 years of age； 3. Histologically or cytologically confirmed solid tumors； 4. At least 1 bone metastasis demonstrated by radiologic imaging or histopathology； 5. Eastern Cooperative Oncology Group performance Status≤2。 6. Life expectancy was judged by the investigators to be at least 6 months; 7. Adequate organ function at Screening 8. Female subjects with a negative blood pregnancy test and are not breastfeeding Exclusion Criteria: 1. Pre-existing or comorbid related oral diseases or oral cavity requiring surgery, etc； 2. History of major joint (e.g., hip, knee, or shoulder) trauma or surgery prior to the first dose of the drug； 3. Received radiotherapeutic drugs or bone radiotherapy prior to the first study drug administration 4. Any cardiovascular disease for which the investigator considers the subject unfit to participate in the study 5. resting tachycardia or resting bradycardia; 6. The subject's pain is predominantly from pain unrelated to the bone metastases; 7. Subject is unable to perform a pain assessment; 8. Symptomatic or treatment-requiring brain metastases or other central nervous system metastases 9. Comorbid infectious disease 10. Prior receipt of exogenous nerve growth factor or anti-nerve growth factor antibodies; 11. Prior history of allergy to relevant drug ingredients or components; 12. Participation in other clinical trials within a certain period of time 13. Subjects who, in the opinion of the investigator, have any other factors
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China