IAH-0968

Phase Ib study: To determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and/or Phase II recommended dose (RP2D) of intravenous IAH0968 combined with GC for adult patients with HER2-positive advanced solid tumors who have failed standard treatment. Phase II study: Using the RP2D determined in the Phase Ib study, it is used as the first-line treatment for patients with HER2-positive advanced or metastatic cholangiocarcinoma (BTC) who have not received systemic treatment. According to RECIST 1.1, the effectiveness of IAH0968 combined with GC and placebo combined with GC is compared by objective remission rate (ORR).

Main study objectives Phase IIa: To evaluate the safety and tolerability of IAH0968 combined with CAPEOX in subjects with HER2-positive advanced or metastatic malignant solid tumors, and to determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D) of the combined treatment. Phase IIb: According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the effectiveness of IAH0968 combined with CAPEOX in subjects with HER2-positive metastatic colorectal cancer was evaluated by progression-free survival (PFS). Phase III: According to RECIST 1.1, the effectiveness of IAH0968 combined with CAPEOX was evaluated by PFS compared with placebo combined with CAPEOX in subjects with HER2-positive metastatic colorectal cancer. Secondary study objectives Phase IIa: To evaluate the pharmacokinetic (PK) characteristics, immunogenicity and preliminary effectiveness of the combination regimen of IAH0968 combined with CAPEOX. Phase IIb/III: To evaluate the safety, tolerability, and immunogenicity of IAH0968 combined with CAPEOX in subjects with HER2-positive metastatic colorectal cancer. Exploratory study objectives To explore the relationship between HER2-related biomarkers and clinical efficacy