Early results from a Phase 1/2 clinical trial suggest that ozekibart (INBRX-109), a targeted antibody, may offer a new option for patients with advanced colorectal cancer who have already received multiple treatments. When combined with standard chemotherapy (FOLFIRI), the drug showed stronger activity than typically seen in late-stage settings.
Among 45 patients, about 20% experienced tumor shrinkage, which is notably higher than the usual 1–6% response rate in this stage of disease. In addition, 87% of patients had their disease controlled, and the median time before cancer progression was 5.5 months. The treatment appeared to work regardless of common genetic mutations such as RAS or RAF.
Side effects were generally manageable and similar to standard chemotherapy, including diarrhea, fatigue, and nausea, mostly mild to moderate. Importantly, no major liver toxicity was reported, even though many patients had cancer spread to the liver.
Based on these findings, Inhibrx Biosciences plans to move forward with further studies, including discussions with the U.S. Food and Drug Administration about potential approval pathways. The company is also exploring use in earlier treatment settings and other cancers.