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2025-08-11 19:18
The Phase 1b study (NCT04900818) is evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig, a potential best-in-class, Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, used in combination with nivolumab and mFOLFOX6, as first line therapy (1L) in patients with CLDN18.2-positive gastric cancers (≥1+ intensity in ≥1% of cells). The primary endpoint is safety. The study enrolled only patients in the U.S. The dose expansion cohorts of the study enrolled a total of 40 patients across two doses (8 mg/kg and 12 mg/kg).