A Study of BPR-6023021 in Advanced Solid Tumors With Bone Metastases (NCT07249892) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of BPR-6023021 in Advanced Solid Tumors With Bone Metastases
China195 participantsStarted 2025-11-19
Plain-language summary
A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of BPR-6023021 in subjects with advanced solid tumors with bone metastases
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The age should be up to 18 years at the time of signing the informed consent form (ICF);
. The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;
. The expected survival period should be ≥ 3 months
. 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
. Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least two site was confirmed by CT or MRI;
. Have adequate organ and bone marrow functions;
. For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration;
. 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
. The washout period before the first administration of the study drug was insufficient.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
. Previous received similar radionuclide internal irradiation treatment.
. Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.
. Known "super bone imaging".
. Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.
. Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.
. Poorly controlled diabetes and hypertension.
. 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.