Clinical Trials Logo
  1. Home
  2. HER2 Gene Mutation
  3. NCT05991518

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

HER2 Gene Mutation Clinical Trial

Official title:
Phase Ib/II Clinical Study of IAH0968 in Combination With Gemcitabine and Cisplatin for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors and Cholangiocarcinoma

Clinical Trial 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.

Clinical Trial Description

Phase Ib is an open-label, non-randomized, multicenter dose-escalation trial. It utilizes the classic "3+3" design to investigate the safety and tolerability of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma. Phase II study is a randomized, double-blind, parallel-controlled, multicenter research design. It aims to investigate the efficacy of IAH0968 in combination with gemcitabine and cisplatin for the treatment of HER2-positive unresectable advanced/metastatic malignant tumors and cholangiocarcinoma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05991518
Study type Interventional
Source SUNHO(China)BioPharmaceutical CO., Ltd.
Contact cao jianxiang, M.D.
Phone 18018039840
Email caojianxiang@sunho-bio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date April 25, 2023
Completion date December 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05511844 - Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors Phase 1
Completed NCT02979821 - Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001) Phase 2
Completed NCT03845270 - Her2-positive Lung Cancer Treated With Dedicated Drug Phase 2
Recruiting NCT05673512 - To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Metastatic Colorectal Cancer Phase 2/Phase 3
Recruiting NCT06383533 - Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma Phase 2
Recruiting NCT05650879 - ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer Phase 1
Active, not recruiting NCT06083662 - Neratinib and Trastuzumab Biosimilar in Patients With HER2 Mutated Advanced Solid Cancers Phase 2
Completed NCT03602079 - Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene Phase 1/Phase 2
Not yet recruiting NCT06178445 - Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer Phase 2
Not yet recruiting NCT03743350 - NSCLC Exon 20 or HER2-activating Mutations Phase 2
Recruiting NCT03412383 - Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer Phase 2
Recruiting NCT06123338 - A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer Phase 2
Recruiting NCT04620187 - Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas Phase 2
Not yet recruiting NCT04179656 - The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor Phase 2
Recruiting NCT06282575 - Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer Phase 3