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Clinical Trials associated with IAH-0968A Phase II/III Clinical Study Evaluating IAH0968 in Combination or Not in Combination With the CAPEOX Regimen in HER2-expressing Advanced/Metastatic Solid Tumors and 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) according to the Research and Evaluation Criteria for the Evaluation of Efficacy in Solid Tumors (RECIST) 1.1.
IAH0968联合吉西他滨及顺铂治疗HER2阳性不可切除的晚期/转移性的恶性肿瘤和胆管癌的Ib/II期临床研究
[Translation] Phase Ib/II clinical study of IAH0968 combined with gemcitabine and cisplatin in the treatment of HER2-positive unresectable advanced/metastatic malignancies and cholangiocarcinoma
Ib 期研究:对于经标准治疗失败的成人 HER2 阳性晚期实体瘤患者,确定静脉滴注 IAH0968 联合 GC 方案的最大耐受剂量( Maximaltolerable dose, MTD)、剂量限制毒性(Dose limited toxicity, DLT)和/或 II 期推荐剂量(RP2D)。
II 期研究:采用 Ib 期研究确定的 RP2D,一线用于未经系统治疗的HER2阳性晚期或转移性胆管癌(BTC)患者, 依据实体瘤疗效评价标准( RECIST) 1.1, 通过客观缓解率( Objective Remission Rate,ORR)对比 IAH0968 联合 GC 方案与安慰剂联合 GC 方案的有效性。
[Translation] 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).
To Evaluate IAH0968 in Combination With CAPEOX in a Phase II/III Clinical Study of HER2-positive Metastatic Colorectal Cancer
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.
100 Clinical Results associated with IAH-0968
100 Translational Medicine associated with IAH-0968
100 Patents (Medical) associated with IAH-0968
100 Deals associated with IAH-0968