NovaBridge Biosciences Enrolls First Patient In Global Phase 2 Trial Of Givastomig With Nivolumab And mFOLFOX6 For HER2-Negative 1L Metastatic Gastric Cancer

NovaBridge Biosciences, a global biotechnology platform company focused on accelerating access to innovative medicines, has announced that it has enrolled the first patient in its global Phase 2 randomized combination study of givastomig. This investigational therapy is a bispecific antibody targeting Claudin 18.2 and 4-1BB, and it is being tested in combination with nivolumab and the mFOLFOX6 chemotherapy regimen for adults with HER2-negative, first-line metastatic gastric cancer. 

The launch of patient enrollment marks an important step in the clinical development of givastomig, which has shown encouraging results in earlier trials. Based on promising Phase 1b findings, givastomig is positioned as a potential best-in-class therapy in the growing market for CLDN18.2-directed treatments, projected to reach $12 billion by 2030. Top-line results from this Phase 2 study are expected in 2027.

Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge, noted that initiation of the Phase 2 trial advances the program closer to commercialization. He explained that the study is built on strong Phase 1b data that demonstrated robust efficacy, good tolerability, and improvements compared with historical standards of care. The new Phase 2 trial aims to confirm those outcomes in a larger population and further evaluate givastomig’s potential across various CLDN18.2 expression ranges in PD-L1-positive patients. Dr. Dennis added that updated results from the Phase 1b dose-expansion stage are expected later this year.

Samuel J. Klempner, MD, Associate Professor of Medicine at the Mass General Brigham Cancer Institute, expressed optimism about the therapy’s trajectory. He highlighted that givastomig has shown high response rates in patients with varying levels of Claudin 18.2 and PD-L1 expression. He also noted that the depth and duration of responses, combined with manageable safety, supported rapid enrollment in the Phase 1b study and provide a strong basis for progressing to Phase 2. Dr. Klempner stated that, if positive results continue, givastomig has the potential to become a future standard of care for gastric and esophageal cancers.

Sean Fu, PhD, MBA, Chief Executive Officer of NovaBridge, commented that starting the Phase 2 trial represents a major milestone as the Company moves into mid-stage clinical development. He said that the earlier efficacy and safety findings reinforce NovaBridge’s confidence in givastomig as a leading CLDN18.2-directed therapy. Fu emphasized that the strong and durable response data support the Company’s belief in the therapy’s commercial potential and align with its mission to develop differentiated treatments that can significantly impact patients worldwide. He added that givastomig is expected to play a central role in NovaBridge’s long-term growth.

The Phase 1b dose-escalation and expansion study previously reported encouraging results, as detailed in a January 2026 press release. Givastomig, administered at doses of 8 mg/kg every two weeks and 12 mg/kg every two weeks, showed a 75% objective response rate among 52 evaluable patients. Responses were observed across wide ranges of PD-L1 and CLDN18.2 expression. The therapy also demonstrated long-lasting activity, with a median progression-free survival of 16.9 months and an 82% progression-free survival rate at six months among 53 evaluable patients. 

Across dosing levels, givastomig showed good overall tolerability when combined with immunochemotherapy and did not exhibit dose-dependent toxicity. More detailed data from the Phase 1b expansion study are expected to be presented at a major medical conference in the second half of 2026, offering additional insights into givastomig’s safety and efficacy as it progresses through clinical development.