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I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
Globenewswireยท 2025-07-02 15:15
Core Insights - I-Mab announced positive Phase 1b combination data for givastomig, showing a confirmed objective response rate (ORR) of 83% at selected doses for ongoing expansion studies [1][2][3] - The study demonstrated favorable tolerability and safety profile, with no Grade 3 or greater events for nausea and vomiting [2][21] - Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB, being developed for first-line treatment of Claudin 18.2-positive gastric cancers [15][18] Study Results - The Phase 1b study showed an overall ORR of 71% across all doses and 83% at doses selected for expansion (8 mg/kg and 12 mg/kg) [2][10] - Responses were observed in tumors with low PD-L1 and/or Claudin 18.2 expression, indicating broad potential for the therapy [2][3] - The disease control rate (DCR) was 100% across all dose levels, with a median follow-up of 9.0 months [12][13] Safety Profile - Treatment-related adverse events (TRAEs) leading to discontinuation were 12%, with common TRAEs being Grade 1 or 2 [21] - No dose-limiting toxicities (DLT) were observed, and a maximum tolerated dose (MTD) was not reached [21] - Grade 3 TRAEs were rare, with only isolated cases reported [21] Future Plans - I-Mab plans to host a virtual investor event on July 8 to discuss the Phase 1b data further [1][4] - The ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment progressing ahead of schedule [16][18]