Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350006
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-01
Brief Title:
SHR-A1904 Combinations in CLDN182-Positive Advanced Solid Tumor
Sponsor:
Shanghai Hengrui Pharmaceutical Co Ltd
Organization:
Shanghai Hengrui Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase IbIII Study of SHR-A1904 Combinations in CLDN182-Positive Advanced Solid Tumor
Status:
RECRUITING
Status Verified Date:
2024-08
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 study consists of two research phases
Phase Ib includes dose escalation phase and efficacy extension phase To explore the safety tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN182-positive advanced solid tumors and to determine the recommended dose and recommended population for the Phase III combination study
Phase III A randomized double-blind multicenter clinical study of SHR-1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN182-positive advanced solid tumors
Phase Ib includes dose escalation phase and efficacy extension phase To explore the safety tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN182-positive advanced solid tumors and to determine the recommended dose and recommended population for the Phase III combination study
Phase III A randomized double-blind multicenter clinical study of SHR-1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN182-positive advanced solid tumors
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