NCT07249892

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.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: Chengdu Syncor Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	BPR-6023021 for injection	BPR-6023021 is a Radionuclide conjugated drugs (RDC) targeting bone.

Timeline

• Start date: 2025-11-19
• Primary completion: 2027-07-30
• Completion: 2027-09-06
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: China