NovaBridge Enrolls First Patient in Phase 2 Study of Givastomig for Gastric Cancer

NovaBridge Biosciences announced enrollment of the first patient in a global Phase 2 randomized study evaluating givastomig in patients with human epidermal growth factor receptor 2 (HER2) negative, first-line metastatic gastric cancer. Top-line Phase 2 results are expected in 2027.

The global randomized Phase 2 study is designed to evaluate the addition of givastomig, at 8 mg/kg and 12 mg/kg doses, to standard of care immunochemotherapy of nivolumab and mFOLFOX6 in patients with first-line metastatic gastric cancer. The study is expected to enroll approximately 180 patients, randomized equally to 8 mg/kg givastomig, 12 mg/kg givastomig, or nivolumab plus mFOLFOX6. The primary endpoint is progression-free survival, with secondary endpoints including objective response rate, overall survival, duration of response, and disease control rate. The study will enroll patients globally.

Givastomig is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies.

The Phase 1b dose expansion data showed that patients treated with givastomig dosed at 8 mg/kg and 12 mg/kg every two weeks experienced an objective response rate of 75%, median progression-free survival of 16.9 months, and 82% six-month landmark progression-free survival. The study demonstrated favorable overall tolerability. Detailed Phase 1b expansion data are expected to be presented at a major medical conference in the second half of 2026.

The Phase 2 study is designed to confirm these results in a broader setting and validate givastomig as a potential best-in-class therapy for first-line metastatic gastric cancer, with the potential for broad utilization across CLDN18.2 levels in Programmed Death-Ligand 1 (PD-L1) positive patients. The study will enroll patients with CLDN18.2-positive gastric cancer, including gastroesophageal cancer, gastroesophageal junction cancer, and gastroesophageal adenocarcinoma, with CLDN18.2 levels of ≥1+ immunohistochemistry intensity on ≥1% of cells, and PD-L1 expression ≥1.

Metastatic gastric cancer occurs when cancer that started in the stomach spreads to other parts of the body, most commonly the liver, peritoneum, lungs, or bones. NovaBridge noted that Phase 1b data, if positive, may position givastomig as a potential CLDN18.2-directed therapy for gastric cancer, with a projected $12 billion market opportunity by 2030.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party.