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To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Metastatic Colorectal Cancer

HER2 Gene Mutation Clinical Trial

Official title:
To Evaluate IAH0968 in Combination With CAPEOX in a Phase II/III Clinical Study of HER2-positive Metastatic Colorectal Cancer

Clinical Trial Summary

The Phase IIa of this clinical study, a dose-escalation study of IAH0968 in combination with CAPEOX, is designed for safety and tolerability in subjects with HER2-positive advanced or metastatic solid tumors. Phase IIb/III is an operational seamless adaptive design consisting of two phases. Phase I (Phase IIb) was designed to initially evaluate the efficacy and safety of IAH0968+CAPEOX in HER2-positive subjects with metastatic colorectal cancer, using PFS.

Clinical Trial Description

The Phase IIa of this clinical study, a dose-escalation study of IAH0968 in combination with CAPEOX regimen, was designed to evaluate Safety and tolerability of IAH0968+CAPEOX regimen in subjects with HER2-positive advanced or metastatic solid tumors. Phase IIb/III uses an operational seamless adaptive design and consists of two phases. Phase I (Phase IIb) aims to initially evaluate the efficacy and safety of IAH0968+CAPEOX in HER2-positive subjects with metastatic colorectal cancer by PFS. Phase II (Phase III) was designed to evaluate the efficacy and safety of IAH0968+CAPEOX versus placebo +CAPEOX in HER2-positive subjects with metastatic colorectal cancer using PFS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05673512
Study type Interventional
Source SUNHO(China)BioPharmaceutical CO., Ltd.
Contact
Status Recruiting
Phase Phase 2/Phase 3
Start date May 12, 2023
Completion date March 1, 2026
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