BR115 for injection will be administered by subcutaneous injection, two doses at the first week of treatment, followed by once per week 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.

BR115 for injection

Ruihua Xu, MD

Rui Xu, MD

This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies.

Patients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study.

A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies

A Phase I Clinical Study of the Safety, Tolerability and Efficacy of BR115 for Injection in Patients With Advanced Solid Malignancies

Adverse events (AEs) will be assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. A treatment-emergent adverse event (TEAE) is defined as an AE that occurred, having been absent before the first dose of study drug.

Defined as participants (who will achieve CR and PR) will be assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR is defined as a disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

TProgression-free survival (PFS) by independent central review is defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause

Overall survival (OS) by independent central review is defined as the time interval from the date of enrollment to the date of death from any cause.

Disease control rate (DCR; defined as participants who will achieve CR, PR, and SD) will be assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR is defined as a disappearance of all target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions.

Duration of response (DoR) by independent central review is defined as the time between the date of the first complete response (CR) or partial response (PR) until the date of the first documentation of progressive disease (PD) or death due to any cause. CR is defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and PD as at least a 20% increase in the sum of diameters of target lesions.

Area under the concentration-time curve of BR115 will be assessed

The anti-drug antibody (ADA) of BR115 will be assessed

Spots Global Cancer Trial Database for br115 for injection