NCT05351697

Clinical Study of BR105 Injection

An Open-label, Dose Escalation and Dose Expansion, Phase I Study of BR105 Injection to Evaluate the Safety, Tolerability and Antitumor Activity in Patients With Advanced Malignant Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: BioRay Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A phase 1, dose escalation and dose expansion study of BR105 in patients with advanced malignancies.

Detailed description

This phase 1 clinical study is an open-label, multiple-dose, dose-escalation, dose-expansion, safety, PK, PD study of BR105. The phase 1 protocol will have 2 parts: a single agent dose escalation phase (Part 1) and dose expansion phase (Part 2). Approximately 40-162 adult patients are expected to be enrolled in the study. The starting dose for phase I is 0.2 mg/kg, followed by 6 dose cohorts (1, 3, 10, 20, 30 and 40 mg/kg). Duration of dose limiting toxicity (DLT) observation is 21 days. Each subject will receive an intravenous infusion of BR105 on day 1 and be observed for 21 days after a single dose. Then Each subject will receive BR105 weekly.

Conditions

• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	BR105 injection	0.2mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg, 40mg/kg respectively

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2022-04-28
• Last updated: 2026-03-17

Locations

1 site across 1 country: China