Second-line ASKB589 plus chemotherapy for advanced gastric or gastroesophageal cancers: Results from cohort 5 of a phase I/II study.

作者：Miao Zhang, Jifang Gong, Jufeng Wang, Huiting Xu, Yinghua Ji, Luwei Han, Jing Chen, Jianfeng Lü, Lin Shen · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.4044 · 被引用次数：3 · 研究领域：Gastric Cancer Management and Outcomes、Colorectal Cancer Treatments and Studies、Helicobacter pylori-related gastroenterology studies

4044 Background: ASKB589 is a humanized monoclonal antibody with enhanced affinity for CLDN18.2 and increased ADCC activity. It has shown favorable safety profiles and promising antitumor effects in phase I/II clinical study (NCT04632108) involving first-line patient(pt)s with advanced gastric or gastroesophageal（G/GEJ） cancers. Here, we present the findings from cohort 5 that ASKB589 in combination with chemotherapy as second-line treatment for patients with advanced G/GEJ cancers. Methods: Cohort 5 from NCT04632108 is designed to evaluate the safety and preliminary efficacy of ASKB589 (at 2 doses: 6mg/kg or 10mg/kg Q3W) plus chemotherapy as second line treatment in pts with G/GEJ cancers. Eligible pts who had confirmed progressive disease during treatment with first line standard of therapy were enrolled. CLDN18.2 statuses were analyzed retrospectively using IHC DS-3 LDT assay. Primary endpoint was safety. Secondary endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression free survival (PFS) assessed by investigator per RECIST v1.1 and overall Survival (OS). Results: As of December 20, 2024, 47 pts were enrolled in the 2L cohort and received 6mg/kg ASKB589 plus chemotherapy. Among them, 44 pts were treated with 6mg/kg ASKB589 plus paclitaxel, while 2 pts received 6mg/kg ASKB589 plus docetaxel, and 1 pt received 6mg/kg ASKB589 plus irinotecan. 17 (27%) pts had received immunotherapy previously.The confirmed ORR was...