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New radioactive drug aims to halt bone metastases in advanced cancers

NCT ID NCT07249892

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 195 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

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