drugset / Trial / NCT05673512

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

NCT05673512

Phase 2/3 Unknown 279 enrolled SUNHO(China)BioPharmaceutical CO., Ltd.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-05-12
Primary completion
2025-03-01
Completion
2026-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject IAH0968 Monoclonal antibody

Indications