To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer

The safety, tolerability, and determination of the maximum tolerated dose (MTD) of the combination therapy were first evaluated for IAH0968 in combination with or without the CAPEOX regimen in unsystematically treated subjects with HER2-expressing advanced/metastatic colorectal or gastric cancers (including adenocarcinomas of the gastro-esophageal junction) or HER2-hypo-expressing advanced/metastatic solid tumors. The efficacy of IAH0968 in combination with the CAPEOX regimen versus trastuzumab in combination with the CAPEOX regimen in subjects with HER2-positive advanced/metastatic gastric cancer, including gastro-esophageal junction adenocarcinoma, was then assessed by progression-free survival (PFS) and OS according to the Research and Evaluation Criteria for the Evaluation of Efficacy in Solid Tumors (RECIST) 1.1.

NCT Number	NCT06504732
Lead Sponsor	SUNHO（China）BioPharmaceutical CO., Ltd.
Conditions	Stomach Neoplasms, Solid Tumor
Enrollment	574 participants
Start Date	2024-08-15
Primary Completion	2028-07 (estimated)
Study Completion	2029-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-05