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 range18 Years

SexALL

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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.
✕. 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.

What they're measuring

Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Timeframe: Up to 1 year

Trial details

NCT IDNCT07249892

SponsorChengdu Syncor Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-30

Contact for this trial

Rui Dong

+8613158775185 rui.dong@btyy.com

View on ClinicalTrials.gov More Metastatic Solid Tumors trials