Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06038058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-08-31
Brief Title:
A Phase I Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies
Sponsor:
BioRay Pharmaceutical Co Ltd
Organization:
BioRay Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase I Clinical Study of the Safety Tolerability and Efficacy of BRY812 for Injection in Patients With Advanced Malignancies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 BRY812 for injection The study objectives are to evaluate the safety tolerability pharmacokinetic profile anti-tumor activity and immunogenicity of BRY812 for injection in patients with advanced malignancies
Patients will receive treatment every 3 weeks until intolerable toxicity disease progression pregnancy withdrawal of informed consent death study discontinuation or withdrawal from the study
Patients will receive treatment every 3 weeks 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?:
None