NCT06001580

A Study of BR101 Injection Alone in Subjects With Advanced Solid Tumors

A Phase Ia Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of BR101 Injection, as a Single Agent in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: BioRay Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase Ia study of single drug BR101 for Advanced solid tumor. The main purpose of this study is to Evaluate the safety and tolerability of BR101monotherapy (single dose and multiple doses) in Subjects with Advanced Solid Tumors and determine the MTD if possible, and determine the RP2D. The secondary purpose of this study is to explore the Pharmacokinetics, Immunogenicity, Antitumor Activity of BR101 monotherapy (single dose and multiple doses) in Subjects with Advanced Solid Tumors

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BR101	BR101 injection was administered once for 28 days observation period and then weekly until the subject experienced unacceptable toxicity, disease progression, poor compliance, pregnancy, informed withdrawal, death, study interruption, and withdrawal from the study

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-10-27
• Completion: 2024-02-07
• First posted: 2023-08-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: China