166
Participants
Start Date
April 30, 2025
Primary Completion Date
August 31, 2028
Study Completion Date
December 31, 2028
BR111 for Injection
BR111-101 for injection will be administered by intravenous drip, 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.
BR111 for Injection
BR111-101 for injection will be administered via intravenous drip at a fixed frequency and cycle until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study occurs. The dose for each administration will be calculated based on the body weight measured prior to administration. The dosing regimen (dosing frequency and interval) for subsequent studies may be adjusted based on prior data. The intravenous drip duration should be ≥ 90 minutes for the first dose and may be adjusted to ≥ 30 minutes for subsequent doses if the first dose is well tolerated.
Fudan University Shanghai Cancer Cancer, Shanghai
Lead Sponsor
BioRay Pharmaceutical Co., Ltd.
INDUSTRY