Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05991518
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-07-26
Brief Title:
IAH0968 in Combination With GC for the Treatment of HER2-Positive Unresectable AdvancedMetastatic Malignant Tumors
Sponsor:
SUNHOChinaBioPharmaceutical CO Ltd
Organization:
SUNHOChinaBioPharmaceutical CO Ltd
Study Overview
Official Title:
Phase IbII Clinical Study of IAH0968 in Combination With Gemcitabine and Cisplatin for the Treatment of HER2-Positive Unresectable AdvancedMetastatic Malignant Tumors and Cholangiocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-02
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:
The study aims to evaluate the efficacy and safety of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advancedmetastatic malignant tumors and cholangiocarcinoma The study is divided into two stages Phase Ib an open-label non-randomized multicenter dose-escalation trial and Phase II a randomized double-blind parallel-controlled multicenter trial
Detailed Description:
Phase Ib is an open-label non-randomized multicenter dose-escalation trial It utilizes the classic 33 design to investigate the safety and tolerability of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advancedmetastatic malignant tumors and cholangiocarcinoma
Phase II study is a randomized double-blind parallel-controlled multicenter research design It aims to investigate the efficacy of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advancedmetastatic malignant tumors and cholangiocarcinoma
Phase II study is a randomized double-blind parallel-controlled multicenter research design It aims to investigate the efficacy of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advancedmetastatic malignant tumors and cholangiocarcinoma
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