Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-02 @ 6:22 AM
Study NCT ID:
NCT06504732
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2024-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer
Sponsor:
SUNHO（China）BioPharmaceutical CO., Ltd.
Organization:
Study Overview
Official Title:
A Phase II/III Clinical Study Evaluating IAH0968 in Combination or Not in Combination With the CAPEOX Regimen in HER2-expressing Advanced/Metastatic Solid Tumors and Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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 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 advanced/metastatic colorectal or gastric cancers (including adenocarcinomas of the gastro-esophageal junction) or HER2-hypo-expressing advanced/metastatic 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 advanced/metastatic 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) 1.1.
Detailed Description:
This clinical study is a randomized, multicenter Phase II/III 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 advanced/metastatic 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 1.1 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 (e.g., development of intolerable adverse reactions), loss to visit, voluntary withdrawal, death, or study termination/suspension.
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 cohorts.The 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 1.1 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 (e.g., development of intolerable adverse reactions), loss to visit, voluntary withdrawal, death, or study termination/suspension.
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 cohorts.The phase III study used a randomized, parallel-controlled, multicenter study design.
Study Oversight
Has Oversight DMC:
False
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?: