New radioactive drug aims to halt bone metastases in advanced cancers
NCT ID NCT07249892
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This clinical trial tests a new drug called BPR-6023021, which is a radioactive compound designed to target bone. It is for people with advanced solid tumors that have spread to the bone and who have no other standard treatment options. The study will enroll 195 participants to evaluate the drug's safety, how it moves through the body, and whether it can slow bone tumor growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BPR-6023021 (a radioactive drug that targets bone)
- What this could lead to
- If it works, this could provide a new treatment option to control bone metastases and delay disease progression in advanced solid tumors.
- What could go wrong
- This is an early-phase trial (Phase I/II) with only 195 participants, so safety and effectiveness are not yet proven. The drug is radioactive, which carries risks of side effects like bone marrow suppression or organ damage.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 195 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 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. The age should be up to 18 years at the time of signing the informed consent form (ICF); 2. The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1; 3. The expected survival period should be ≥ 3 months 4. Phase I and phase II: Subjects with advanced solid tumor bone metastases diagnosed by histology or cytology; and the subjects have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to standard treatment 5. Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least two site was confirmed by CT or MRI; 6. Have adequate organ and bone marrow functions; 7. For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration; 8. The subjects voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures stipulated in the protocol. Exclusion Criteria 1. The washout period before the first administration of the study drug was insufficient. 2. Previous received similar radionuclide internal irradiation treatment. 3. Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases. 4. Known "super bone imaging". 5. Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression. 6. Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug. 7. Poorly controlled diabetes and hypertension. 8. The toxicity of previous anti-tumor treatment before the first administration has not recovered to ≤ 1 grade (evaluated based on NCI-CTCAE v5.0) or has not reached the level specified in the inclusion/exclusion criteria. 9. Had other malignant tumors within 5 years before the first administration. 10. Subjects with severe and/or uncontrolled concomitant diseases. 11. Active hepatitis B or active hepatitis C. 12. Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection. 13. During the screening process before the first administration, the condition deteriorated rapidly, such as significant changes in the investigator's assessment of physical condition, etc.
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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
Guangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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