Spots Global Cancer Trial Database for A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies
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Trial Identification
Brief Title: A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies
Official Title: A Phase I Clinical Study of the Safety, Tolerability and Efficacy of BR115 for Injection in Patients With Advanced Solid Malignancies
Study ID: NCT06388902
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Contact Details
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