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I-Mab Completes Enrollment in Planned Phase 1b Dose Expansion Study for Givastomig in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers
Globenewswire· 2025-08-11 11:00
Core Viewpoint - I-Mab has successfully completed enrollment in the Phase 1b dose expansion cohorts for givastomig, a bispecific antibody targeting Claudin 18.2, ahead of expectations, indicating strong interest and unmet needs in gastric cancer therapy [1][3]. Group 1: Study Details - The Phase 1b study (NCT04900818) is focused on evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of givastomig in combination with nivolumab and mFOLFOX6 for CLDN18.2-positive gastric cancers [2]. - A total of 40 patients were enrolled in the dose expansion cohorts, with two doses being tested: 8 mg/kg and 12 mg/kg [2]. - The primary endpoint of the study is safety, and it exclusively enrolled patients in the U.S. [2]. Group 2: Clinical Data and Results - Data presented at the ESMO GI 2025 indicated an 83% objective response rate (ORR) for givastomig in combination with immunochemotherapy at the selected doses [3][8]. - The response onset was reported to be rapid, durable, and deepened over time, with favorable overall safety [3]. Group 3: Product Overview - Givastomig is a bispecific antibody designed to target Claudin 18.2-positive tumor cells and conditionally activate T cells through the 4-1BB signaling pathway [4][7]. - The drug is being developed for first-line metastatic gastric cancers, with potential applications in other solid tumors [4][7]. Group 4: Development Partnership - Givastomig is being developed through a global partnership with ABL Bio, where I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio [6]. Group 5: Future Expectations - The company expects to release topline results from the Phase 1b study in Q1 2026, following the positive data from the dose escalation phase [8].
I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
Globenewswire· 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]