A Study of BR111 in Patients With Advanced Malignancies

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

December 31, 2028

Conditions
Advanced Malignancies
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

No. 4333, Kangxin Road

Fudan University Shanghai Cancer Cancer, Shanghai

All Listed Sponsors
lead

BioRay Pharmaceutical Co., Ltd.

INDUSTRY