Davendra Sohal, MD, MPH
Gastrointestinal Cancer
Phase 1
DB 1324 in Gastrointestinal Cancer
This first-in-human study will test DB-1324 in people with advanced or metastatic gastrointestinal (GI) cancers. The study has two main phases. Phase 1 uses dose escalation and expansion steps to find a safe and tolerable dose and to learn how the drug behaves in the body. Phase 2 will further check safety and look for signs the drug can help certain GI cancers. Participants will get DB-1324 regularly until their disease worsens, they have unacceptable side effects, they choose to stop, or another reason for stopping occurs. Researchers will watch for side effects, serious adverse events, and dose-limiting toxicities to find the maximum tolerated dose and recommended doses for later studies. The study will also measure tumor response, how long any responses last, time until progression, and drug levels in the blood. Participants will need to provide tumor tissue or allow a biopsy for testing biomarkers such as CDH17.
This study may be appropriate for those with: Metastatic Cancer