A Study of BPR-6023021 in Advanced Solid Tumors With Bone Metastases

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

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Solid Tumors
• Intervention / Treatment: Drug: BPR-6023021 for injection

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 Type: Interventional
• Enrollment (Estimated): 195
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rui Dong; Phone Number: +8613158775185; Email: rui.dong@btyy.com
• Study Contact Backup: Name: Ruofei Tong; Phone Number: +86-18002098164; Email: ruofei.tong@btyy.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun yat-sen University Cancer Center
      • Contact: Wei Fan, M.D.; Phone Number: +86-20-87343415; Email: fanwei@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1:Dose escalation; 5 dose levels of BPR-6023021 are tentatively planned for Phase 1	Drug: BPR-6023021 for injection; BPR-6023021 is a Radionuclide conjugated drugs (RDC) targeting bone.
Experimental: Phase 2: RP2D Cohort; 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.	Drug: BPR-6023021 for injection; BPR-6023021 is a Radionuclide conjugated drugs (RDC) targeting bone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetry，including Maximum plasma concentration (Cmax) of BPR-6023021	To collect the biological distribution of major tissues/organs and so on.	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	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	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.	Through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Chengdu Syncor Pharmaceutical Co., Ltd.
• Collaborators: Beijing Quarkxia Technology Co., Ltd.
• Investigators: Study Director: Yan Yang, Chengdu Syncor Pharmaceutical Co., Ltd.; Principal Investigator: Wei Fan, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): November 19, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 6, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Advanced Solid Tumors; Bone Metastases; BPR-6023021
• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: BPR-6023021-101; CTR20254494 (Registry Identifier: National Medical Products Administration (NMPA) Drug Clinical Trial Registration And Information Publicity Platform)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No