NCT06388902

A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies

A Phase I Clinical Study of the Safety, Tolerability and Efficacy of BR115 for Injection in Patients With Advanced Solid Malignancies

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: BioRay Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies. Patients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study.

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	BR115 for injection	BR115 for injection will be administered by subcutaneous injection, two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation or withdrawal from the study. The dose of each administration will be calculated based on the weight measured prior to such administration. The dosing regimen (dosing frequency and interval) for subsequent study may be adjusted based on prior data.

Timeline

• Start date: 2024-02-19
• Primary completion: 2028-08-01
• Completion: 2028-12-01
• First posted: 2024-04-29
• Last updated: 2025-11-21

Locations

1 site across 1 country: China