Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT06388902
Status:
SUSPENDED
Last Update Posted:
2025-11-21
First Post:
2024-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies
Sponsor:
BioRay Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Clinical Study of the Safety, Tolerability and Efficacy of BR115 for Injection in Patients With Advanced Solid Malignancies
Status:
SUSPENDED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to drug stability and global interests, it is currently in a suspended state.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: