NCT06038058

A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies

A Phase I Clinical Study of the Safety, Tolerability and Efficacy of BRY812 for Injection in Patients With Advanced Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 164 (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 BRY812 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BRY812 for injection in patients with advanced malignancies. Patients will receive treatment every 3 weeks until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study.

Conditions

• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	BRY812 for injection	BRY812 for injection will be administered by intravenous drip, tentatively once per cycle spanning 3 weeks on D1 of each cycle 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. The intravenous drip should last for ≥ 90 min for the first dose and may be adjusted to ≥ 30 min for subsequent doses if the first dose is tolerable.

Timeline

• Start date: 2023-10-10
• Primary completion: 2028-08-01
• Completion: 2028-12-01
• First posted: 2023-09-14
• Last updated: 2025-12-30

Locations

1 site across 1 country: China