In November 2025, clinical research teams activated a phase 1 trial, led locally by Deepak Kilari, MD, Associate Professor of Hematology and Oncology, to evaluate the safety, early signs of anti-tumor activity, and the recommended phase 2 dose of a new therapy, TEV-56278, given alone or with pembrolizumab in people with locally advanced or metastatic solid tumors.
TEV-56278 is designed with two key components:
- An antibody that identifies immune cells already engaged in fighting cancer
- An IL-2 signal that strengthens those cells and helps them work harder
“The idea is to supercharge the body’s own cancer-fighting cells while avoiding the side effects that usually happen when IL-2 is given broadly,” Dr. Kilari said. “Unlike current drugs, TEV-56278 doesn’t block the usual PD-1 pathway, so it can be safely paired with pembrolizumab.”
Pembrolizumab (KEYTRUDA®) is an established immunotherapy used to treat several cancer types. TEV-56278 may have the strength to shrink tumors on its own, but researchers hope the combination will produce a stronger, more durable response. Key outcomes for this phase 1 study include adverse events, recommended phase 2 dose, objective response rate, and duration of response.
“For people who have tried everything and seen no results, this trial offers hope,” Dr. Kilari said. “It could provide another chance at slowing down or controlling their cancer.” He noted that because MCW is participating early, patients across Wisconsin have access to TEV-56278 before it is available elsewhere.