drugset
drugset / Trial / NCT05991518

IAH0968 in Combination With GC for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors

NCT05991518 ↗

Phase 1/2 Unknown 136 enrolled SUNHO（China）BioPharmaceutical CO., Ltd.
RandomizedSequentialTriple-blindTreatment

Summary

The study aims to evaluate the efficacy and safety of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma. The study is divided into two stages: Phase Ib, an open-label, non-randomized, multicenter dose-escalation trial, and Phase II, a randomized, double-blind, parallel-controlled, multicenter trial.

Timeline

Start
2023-04-25
Primary completion
2024-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject IAH0968 Monoclonal antibody — Intravenous
Background Cisplatin Other / unclassified 70 mg/m2 —
Background Gemcitabine Small molecule 1000 mg/m2 —

Indications

carcinoma