Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321913
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-23
Brief Title:
Study of IBI343 in Subjects With Advanced GastricGastroesophageal Junction Adenocarcinoma
Sponsor:
Harbin Medical University
Organization:
Harbin Medical University
Study Overview
Official Title:
Phase II Study to Evaluate the Safety Tolerability and Efficacy of IBI343 Combined With Sintilimab in Subjects With Advanced GastricGastroesophageal Junction Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 goal of this clinical trial is toevaluate the safety tolerability and efficacy of IBI343 combined with sintilimab in the treatment of subjects with advanced gastricgastroesophageal junction adenocarcinoma The main aim is to evaluate the efficacy and safety of IBI343 combination treatment in subjects with advanced gastricgastroesophageal junction adenocarcinomaThe secondary aim is to evaluate other efficacy endpoints in subjects with IBI343 combination therapy for advanced gastricgastroesophageal junction adenocarcinomaThe exploratory purpose is to evaluate the correlation between CLDN182 expression levels in tumor tissues and the efficacy of IBI343 combination therapy
Participants will be asked to enroll about 3-12 patients in the safety introduction periodand about 25 patients are planned to be enrolled in the POC phase
Participants will be asked to enroll about 3-12 patients in the safety introduction periodand about 25 patients are planned to be enrolled in the POC phase
Detailed Description:
The goal of this clinical trial is toevaluate the safety tolerability and efficacy of IBI343 combined with sintilimab in the treatment of subjects with advanced gastricgastroesophageal junction adenocarcinoma The main aim is to evaluate the efficacy and safety of IBI343 combination treatment in subjects with advanced gastricgastroesophageal junction adenocarcinomaThe secondary aim is to evaluate other efficacy endpoints in subjects with IBI343 combination therapy for advanced gastricgastroesophageal junction adenocarcinoma
Participants will be asked to enroll about 3-12 patients in the safety introduction periodand about 25 patients are planned to be enrolled in the POC phase
Participants will be asked to enroll about 3-12 patients in the safety introduction periodand about 25 patients are planned to be enrolled in the POC phase
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