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

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.

Timeline

Start

2024-02-19

Primary completion

2028-08

Completion

2028-12

Outcome

Outcome not reported

Stopped: “Due to drug stability and global interests, it is currently in a suspended state.”

Drugs

Indications