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

NCT07249892 | Not Yet Recruiting Phase 1

• 2 other identifiers: BPR-6023021-101CTR20254494
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Metastatic Solid Tumors

Keywords

BPR-6023021; Advanced Solid Tumors; Bone Metastases

Outcome Measures

Primary Outcomes (1)

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

  Up to 1 year

Secondary Outcomes (4)

• Dosimetry，including Maximum plasma concentration (Cmax) of BPR-6023021

  Through study completion, an average of 2 year

• Time to Radiographic Bone Progresion (TTRBP)

  Through study completion, an average of 2 year

• Radiographic progression-free survival (rPFS)

  Through study completion, an average of 2 year

• Symptomatic skeletal event-free survival (SSE-FS)

  Through study completion, an average of 2 year

Study Arms (2)

Phase 1:Dose escalation

EXPERIMENTAL

5 dose levels of BPR-6023021 are tentatively planned for Phase 1

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.

Drug: BPR-6023021 for injection

Interventions

BPR-6023021 for injection DRUG

BPR-6023021 is a Radionuclide conjugated drugs (RDC) targeting bone.

Phase 1:Dose escalation; Phase 2: RP2D Cohort

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chengdu Syncor Pharmaceutical Co., Ltd.: lead
• Beijing Quarkxia Technology Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yan Yang

  Chengdu Syncor Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

• Wei Fan

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Dong

CONTACT

+8613158775185; rui.dong@btyy.com

Ruofei Tong

CONTACT

+86-18002098164; ruofei.tong@btyy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 25, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 6, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)