I-Mab(US:IMAB) Globenewswire·2025-06-26 10:30Core Insights - I-Mab announced positive data from a Phase 1b study of givastomig in combination with nivolumab and mFOLFOX6 for metastatic gastric cancers, showing an objective response rate (ORR) of 71% across all dose levels and 83% in the selected dose expansion cohort [1][2][3] Study Details - The Phase 1b study evaluated the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig as first-line therapy in Claudin 18.2-positive gastric cancers, with a primary endpoint focused on safety [2][18] - The study enrolled 17 treatment-naïve patients with advanced metastatic gastric, esophageal, or gastroesophageal adenocarcinomas [6][18] Efficacy Results - Overall, 71% (12/17) of patients achieved a partial response (PR) per RECIST v1.1, with a higher response rate of 83% (10/12) in the dose levels selected for expansion (8 and 12 mg/kg) [9][13] - The disease control rate (DCR) was reported at 100% across all dose levels [13] - Notably, responses were observed in patients with low PD-L1 and/or CLDN18.2 expression [1][3] Safety Profile - The safety profile of givastomig was favorable, with no dose-limiting toxicities (DLT) observed and a maximum tolerated dose (MTD) not reached [14][15] - Common treatment-related adverse events (TRAEs) were generally Grade 1 or Grade 2, including nausea, vomiting, and fatigue, with rare Grade 3 TRAEs reported [14][15] Upcoming Events - Updated results from the study will be presented at the ESMO GI 2025 on July 2nd, and the company will host a virtual investor event on July 8th to discuss the findings [1][12]