Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504732
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIII Clinical Study Evaluating IAH0968 in Combination or Not in Combination With the CAPEOX Regimen in HER2-expressing AdvancedMetastatic Solid Tumors and Gastric Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The safety tolerability and determination of the maximum tolerated dose MTD of the combination therapy were first evaluated for IAH0968 in combination with or without the CAPEOX regimen in unsystematically treated subjects with HER2-expressing advancedmetastatic colorectal or gastric cancers including adenocarcinomas of the gastro-esophageal junction or HER2-hypo-expressing advancedmetastatic solid tumors The efficacy of IAH0968 in combination with the CAPEOX regimen versus trastuzumab in combination with the CAPEOX regimen in subjects with HER2-positive advancedmetastatic gastric cancer including gastro-esophageal junction adenocarcinoma was then assessed by progression-free survival PFS according to the Research and Evaluation Criteria for the Evaluation of Efficacy in Solid Tumors RECIST 11
Detailed Description:
This clinical study is a randomized multicenter Phase IIIII clinical study to investigate the efficacy of IAH0968 in combination or not in combination with the CAPEOX regimen in the treatment of subjects with HER2-expressing advancedmetastatic solid tumors and gastric cancer The study is divided into two study phases a Phase II clinical study and a Phase III clinical study
Adverse events and adverse reactions were assessed in the study through clinical observation vital signs monitoring laboratory tests etc while PK ADA and other relevant samples were collected and using RECIST 11 as the standard for tumor assessment subjects were assessed for tumors every 6 weeks starting from the first infusion of the study drug until the occurrence of disease progression the initiation of new antitumor therapy and the judgement of the investigator that it was not suitable for continued participation eg development of intolerable adverse reactions loss to visit voluntary withdrawal death or study terminationsuspension
Upon withdrawal or termination of treatment 7 days subjects should be visited for termination of treatment except in the case of death and loss to follow-up as far as possible prior to the initiation of new antitumor therapy with relevant laboratory investigations and ADA samples and thereafter followed up by telephone every 12 weeks 7 days for survival OS until loss to follow-up or death
The phase II study was an open-label nonrandomized clinical study which was planned to be divided into 3 cohortsThe phase III study used a randomized parallel-controlled multicenter study design
Adverse events and adverse reactions were assessed in the study through clinical observation vital signs monitoring laboratory tests etc while PK ADA and other relevant samples were collected and using RECIST 11 as the standard for tumor assessment subjects were assessed for tumors every 6 weeks starting from the first infusion of the study drug until the occurrence of disease progression the initiation of new antitumor therapy and the judgement of the investigator that it was not suitable for continued participation eg development of intolerable adverse reactions loss to visit voluntary withdrawal death or study terminationsuspension
Upon withdrawal or termination of treatment 7 days subjects should be visited for termination of treatment except in the case of death and loss to follow-up as far as possible prior to the initiation of new antitumor therapy with relevant laboratory investigations and ADA samples and thereafter followed up by telephone every 12 weeks 7 days for survival OS until loss to follow-up or death
The phase II study was an open-label nonrandomized clinical study which was planned to be divided into 3 cohortsThe phase III study used a randomized parallel-controlled multicenter study design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None