New injection aims to ease bone cancer pain and prevent fractures
NCT ID NCT06380881
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested an investigational drug called SHR-2017 in 25 adults with solid tumors that spread to the bone. The goal was to see how the drug moves through the body, whether it reduces pain and bone complications, and how safe it is. Participants had at least one bone metastasis and moderate to severe pain despite stable pain medication.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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May 2024
- Finished
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Aug 2025
- 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, age ≥ 18 years; 3. Solid tumors confirmed by histological or cytological examination; 4. At least 1 bone metastasis from a documented tertiary A hospital during the screening period; 5. Worst pain score NRS ≥5 points when treated with a stable analgesic regimen during the baseline assessment period; 6. Received a stable anti-tumor regimen within 28 days prior to the baseline assessment period 7. During the screening period, the physical status score of the Eastern Cooperative Oncology Group (ECOG) was 0-2 points; 8. Life expectancy judged by the investigator to be at least 6 months 9. Good organ function during the screening period (repeated testing can be confirmed if necessary); 10. Female subjects of childbearing potential with negative blood pregnancy test results within 7 days prior to the first dose of study drug and not lactating. Exclusion Criteria: 1. Previous occurrence or concomitant osteomyelitis of the jaw or osteonecrosis of the jaw, dental disease or jaw disease that is active, requiring oral surgery, dental surgery or oral surgery wound that has not fully healed, or has planned invasive dental procedures during the study; 2. History of major joint trauma or surgery within 1 year prior to enrollment 3. Cardiac dysfunction Within 6 months before enrollment; 4. Resting tachycardia or resting bradycardia on ECG at screening; 5. Subjects who have evidence of orthostatic hypotension at screening; 6. Hepatitis B surface antigen (HBSAG), hepatitis C antibody (HCVAB), human immune defect antivirus (HIV) antibody, syphilis antibody; 7. The pain of the subjects not predominantly related to a bone metastasis; 8. The subject with neurological diseases and/or mental illness and/or cognitive dysfunction ; 9. Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 1 month of the treatment period, and the subject who received the radiotherapy within one month before the first research drug administration 10. Subject has a history of allergic or anaphylactic reaction to mammalian -based drugs, or allergies to supplements (calcium or vitamin D supplements), or have a history of allergens of opioids, or past history of treatment or diagnostic monoclonal antibody, Or other allergies; 11. The subject participated in the treatment of other clinical trials within one month before receiving the experimental drug (except for participating in other clinical trial screening losers); 12. In the judgment of the investigator, would make the subject inappropriate for entry into this study;
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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.
Contacts and locations
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China