Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06115902
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-10-30
Brief Title:
A Study of TQB2102 for Injection in Patients With RecurrentMetastatic Breast Cancer
Sponsor:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co Ltd
Organization:
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Study Overview
Official Title:
A Phase 1 Clinical Trial of TQB2102 for Injection in Patients With Human Epidermal Growth Factor Receptor 2 HER2 -Expressing RelapsedMetastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-10
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:
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 HER2 an enzyme-cleavable linker and a topoisomerase I inhibitor payload which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration This is a Phase 1Phase 2 study to evaluate the effectiveness safety pharmacokinetics PK and anti-drug antibody ADA of TQB2102 for injection in subjects with HER2-expressing relapsedmetastatic breast cancer
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