NCT05673512

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 279 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HER2 Gene Mutation

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Injection of IAH0968 + CAPEOX	PLACEBO+CAPEOX in HER2 positive metastatic colorectal cancer patient
COMBINATION_PRODUCT	PLACEBO+CAPEOX	PLACEBO+CAPEOX in HER2 positive metastatic colorectal cancer patient

Timeline

• Start date: 2023-05-12
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2023-01-06
• Last updated: 2024-02-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study