Metastatic Solid TumorsPhase 1/2NCT07249892
A Study of BPR-6023021 in Advanced Solid Tumors With Bone Metastases
A Phase 1/2 study testing BPR-6023021 for injection in people with Metastatic Solid Tumors, run by Chengdu Syncor Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumors
- What is being tested?
- BPR-6023021 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2025to 6 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Had other malignant tumors within 5 years before the first administration.
- Subjects with severe and/or uncontrolled concomitant diseases.
- Active hepatitis B or active hepatitis C.
- Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Wei Fan, M.D., +86-20-87343415, fanwei@sysucc.org.cn
About this study
Official title: A Multicenter, Open-label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Dosimetry and Efficacy of BPR-6023021 in Subjects With Advanced Solid Tumors With Bone Metastases.
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
Read the detailed description
This study is 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. The study is divided into two parts: Phase I and Phase II. The Phase I study is the dose escalation phase. The primary objective is to assess the safety and tolerability of a single administration of BPR-6023021 and to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) based on the occurrence of Dose-Limiting Toxicities (DLTs) associated with BPR-6023021 (if the MTD cannot be determined).The Phase II study is the dose expansion phase. The primary objective is to explore the efficacy of BPR-6023021 at a selected dose level.
- Conditions
- Metastatic Solid Tumors
- Being tested
- BPR-6023021 for injection
- Keywords
- BPR-6023021, Advanced Solid Tumors, Bone Metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPR-6023021 for injectionDrug
BPR-6023021 is a Radionuclide conjugated drugs (RDC) targeting bone.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1:Dose escalation | Experimental | 5 dose levels of BPR-6023021 are tentatively planned for Phase 1 Receives: Drug: BPR-6023021 for injection |
| Phase 2: RP2D Cohort | Experimental | Participants will receive BPR-6023021 for injection at the Recommended Phase 2 Dose (RP2D) determined from the Phase 1 dose escalation study.The dose of BPR-6023021 for injection in Phase 2 is selected based on the Phase 1 monotherapy dose escalation study. Receives: Drug: BPR-6023021 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Up to 1 year
Secondary outcomes (4)
Dosimetry，including Maximum plasma concentration (Cmax) of BPR-6023021
To collect the biological distribution of major tissues/organs and so on.
Measured: Through study completion, an average of 2 year
Time to Radiographic Bone Progresion (TTRBP)
Time from start of treatment to progression of bone lesion (PD) or death, whichever occurs first, during the study period
Measured: Through study completion, an average of 2 year
Radiographic progression-free survival (rPFS)
Time from start of treatment to progression of Disease (PD) or death, whichever occurs first
Measured: Through study completion, an average of 2 year
Symptomatic skeletal event-free survival (SSE-FS)
Time from start of treatment to the first occurrence of new SSE or death from any cause , whichever occurs first.
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start19 Nov 2025 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Syncor Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Quarkxia Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yan Yang, Study director, Chengdu Syncor Pharmaceutical Co., Ltd.Wei Fan, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249892
- Sponsor's protocol ID
- BPR-6023021-101
- Other IDs
- CTR20254494
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected in this study are considered confidential commercial information of the sponsor. Therefore, they will not be shared publicly to protect intellectual property and maintain competitive advantage.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Dosimetry and Efficacy of BPR-6023021 in Subjects With Advanced Solid Tumors With Bone Metastases.
- ClinicalTrials.gov ID
- NCT07249892
- Acronym / sponsor ID
- BPR-6023021-101
- Conditions
- Metastatic Solid Tumors
- Keywords
- BPR-6023021, Advanced Solid Tumors, Bone Metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Chengdu Syncor Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Quarkxia Technology Co., Ltd.
- Study start
- 19 Nov 2025 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is 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. The study is divided into two parts: Phase I and Phase II. The Phase I study is the dose escalation phase. The primary objective is to assess the safety and tolerability of a single administration of BPR-6023021 and to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) based on the occurrence of Dose-Limiting Toxicities (DLTs) associated with BPR-6023021 (if the MTD cannot be determined).The Phase II study is the dose expansion phase. The primary objective is to explore the efficacy of BPR-6023021 at a selected dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1:Dose escalation | Experimental | Drug: BPR-6023021 for injection5 dose levels of BPR-6023021 are tentatively planned for Phase 1 |
| Phase 2: RP2D Cohort | Experimental | Drug: BPR-6023021 for injectionParticipants will receive BPR-6023021 for injection at the Recommended Phase 2 Dose (RP2D) determined from the Phase 1 dose escalation study.The dose of BPR-6023021 for injection in Phase 2 is selected based on the Phase 1 monotherapy dose escalation study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPR-6023021 for injectionBPR-6023021 is a Radionuclide conjugated drugs (RDC) targeting bone. | Drug | Phase 1:Dose escalation, Phase 2: RP2D Cohort |
Primary outcome
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to 1 year
4 secondary outcomes
Dosimetry，including Maximum plasma concentration (Cmax) of BPR-6023021
Time frame: Through study completion, an average of 2 year
Time to Radiographic Bone Progresion (TTRBP)
Time frame: Through study completion, an average of 2 year
Radiographic progression-free survival (rPFS)
Time frame: Through study completion, an average of 2 year
Symptomatic skeletal event-free survival (SSE-FS)
Time frame: Through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected in this study are considered confidential commercial information of the sponsor. Therefore, they will not be shared publicly to protect intellectual property and maintain competitive advantage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Yang study director
Chengdu Syncor Pharmaceutical Co., Ltd.
Wei Fan principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BPR-6023021 for injection in people with Metastatic Solid Tumors, run by Chengdu Syncor Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Dong (+8613158775185, rui.dong@btyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.