I-Mab, a global biotech company, announced the completion of enrollment, ahead of schedule, in the first dose expansion cohort of a Phase 1b study for givastomig. Givastomig is a Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody being studied for first-line treatment of gastric cancer. The first patient in the second expansion cohort has also been dosed, and topline results from the 40-patient dose expansion study are expected in the first half of 2026. Data from the Phase 1b dose escalation study are expected in the latter half of 2025.
This rapid enrollment signifies strong interest in givastomig’s potential to address a critical unmet need in gastric cancer treatment. The combination of CLDN18.2 targeting with 4-1BB activation offers a novel approach, potentially improving efficacy beyond current standard treatments which include chemotherapy and anti-PD-1 checkpoint inhibitors. Early completion of enrollment suggests efficient trial execution and high patient interest, potentially accelerating development timelines. Positive results could pave the way for larger-scale trials and ultimately offer a new treatment option for patients with this aggressive form of cancer.
The Phase 1b study is evaluating givastomig in combination with the current standard of care (nivolumab and chemotherapy) for first-line treatment of gastric cancer. It includes a dose escalation study (n=17, completed) and a dose expansion study (n=40). Previous Phase 1 monotherapy data demonstrated givastomig’s strong tumor-binding properties and anti-tumor activity, along with a tolerable safety profile. I-Mab is co-developing givastomig in a global partnership with ABL Bio, holding worldwide rights excluding Greater China and South Korea.
Successful results from this Phase 1b study could position givastomig as a leading therapy in first-line gastric cancer treatment. This would represent a significant advancement in the field, offering a new and potentially more effective option for patients. The expedited enrollment and positive preliminary data suggest a promising outlook for givastomig’s continued development and potential future approval.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
