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

Phase 2

Recruiting

• Conditions: HER2 Gene Mutation
• Interventions: Combination Product: Injection of IAH0968 + CAPEOX; Combination Product: PLACEBO+CAPEOX

• Registration Number: NCT05673512
• Lead Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-06
• Study Start: 2023-05-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IAH0968+ CAPEOX	Injection of IAH0968 + CAPEOX	IAH0968+ CAPEOX in HER2 positive metastatic colorectal cancer patient
CAPEOX	PLACEBO+CAPEOX	PLACEBO+CAPEOX in HER2 positive metastatic colorectal cancer patient

Primary Outcome Measures

Name	Time	Method
Progression-Free-Survival（PFS）	12 months	treatment index

Trial Locations

Locations (1)

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China