About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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".
Trial design
Treatments tested in this trial
- BPR-6023021 for injection
Treatment groups
Sponsors and collaborators
Chengdu Syncor Pharmaceutical Co., Ltd.
Lead sponsor
Beijing Quarkxia Technology Co., Ltd.
Collaborator