NovaBridge Biosciences announced the enrollment of the first patient in its global, randomized Phase 2 study of the Claudin 18.2 × 4‑1BB bispecific antibody givastomig combined with nivolumab and mFOLFOX6 chemotherapy for HER2‑negative, first‑line metastatic gastric cancer. The trial will enroll approximately 180 patients worldwide and is designed to evaluate the safety and efficacy of this novel combination.
The study employs two dosing levels of givastomig—8 mg/kg and 12 mg/kg—based on the optimal doses identified in Phase 1b. Inclusion criteria require CLDN18.2‑positive gastric cancer with ≥1+ IHC intensity on ≥1% of cells and PD‑L1 expression ≥1. This design builds on the Phase 1b data that showed a 75% objective response rate, a 16.9‑month median progression‑free survival, and an 82% six‑month landmark PFS.
Phase 1b results provide a strong rationale for advancing to Phase 2, and the trial could shape NovaBridge’s regulatory strategy and partnership opportunities. The combination of givastomig with nivolumab and mFOLFOX6 leverages the established first‑line standard of care while targeting the unmet need in HER2‑negative disease through CLDN18.2 expression.
The gastric cancer market is projected to reach $12 billion by 2030, underscoring the commercial potential of a best‑in‑class therapy. Givastomig’s targeted approach and the robust Phase 1b efficacy data position it as a promising candidate to address a significant unmet need in a large, growing market.
CEO Sean Fu said the enrollment marks a pivotal moment for NovaBridge, validating givastomig’s potential as a premier CLDN18.2‑directed therapy. Chief Medical Officer Phillip Dennis highlighted the study’s goal to confirm Phase 1b results in a broader setting and expand the patient population.
The first‑patient enrollment signals progress toward top‑line data in 2027, advancing the program and potentially opening regulatory and partnership pathways. This milestone underscores NovaBridge’s pipeline momentum and positions the company to address a significant unmet need in metastatic gastric cancer.
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