NCI-2025-05085

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB1305 in Participants with Advanced/Metastatic Solid Tumors

This Phase 2, multicenter, open-label research study is evaluating the experimental drug DB-1311—given in combination with either BNT327 or DB-1305—in people with advanced or metastatic solid tumors. These are cancers that have spread to other parts of the body or have stopped responding to standard treatments. DB-1311 is an antibody–drug conjugate (ADC), a targeted cancer therapy that combines a monoclonal antibody (which recognizes specific proteins on cancer cells) with a potent chemotherapy drug. This design allows for the precise delivery of the cancer-killing agent directly to tumor cells, aiming to maximize cancer destruction while reducing side effects. The partner drugs—BNT327 and DB-1305—are also investigational agents designed to complement DB-1311’s activity, either by enhancing immune response or attacking cancer through a different biological pathway. By testing DB-1311 in combination with BNT327 or DB-1305, the goal is to determine whether these drug pairings can produce stronger anti-cancer effects and help patients with various advanced solid tumors that have limited treatment options.

Phase 2: An advanced point of testing, where they're trying to confirm if a treatment works well.

open-label: Patients know which treatments are being given to them

antibody–drug conjugate: an antibody that targets cancer cells and a chemotherapy drug that kills cancer cells.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT06953089

Clinical Trial Site: Columbia

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