Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy

This is a single institution, open-label phase I trial that aims to assess the safety of combination sacituzumab govitecan plus capecitabine in the treatment of patients with gastrointestinal cancers after progression on standard therapy. Gastrointestinal cancers eligible include pancreaticobiliary cancers, colorectal cancers, and upper gastrointestinal cancers such as esophageal, gastroesophageal junction, and gastric cancers. The trial follows a 3 + 3 design and has three planned dose levels. The starting dose of sacituzumab govitecan is 7.5mg/kg intravenously on Days 1 and 8. The starting dose of capecitabine is 500mg/m2 orally twice daily for two weeks on and one week off. Plan is accrue a total of 20 patients. The primary endpoint is the recommended phase 2 dose (RP2D) Secondary Endpoints include adverse events, objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS), There is an exploratory endpoint of the correlation between Trop-2 expression and clinical outcomes. Patients will be recruited from the Gastrointestinal (GI) Medical Oncology clinics within the Henry Ford Cancer Institute (HFCI) campuses. The study is divided into a Screening period, Treatment period, End of Treatment (EOT) period, and Follow-up period. During Screening period patients will provide written informed consent (ICF) to participate in the study before completing any protocol-specified procedures or evaluations not considered to be part of the patient's standard care. Procedures that were performed for standard of care prior to signing informed consent may be used for screening purposes (e.g., full physical exam) as long as the procedures were completed within the 28-day screening period. After signing the ICF, patients will be evaluated for entry criteria during the screening period within 28 days before administration of study drugs. Rescreening after screen failure will be allowed. Treatment will continue until unacceptable toxicity, death, progression of disease (PD) per RECIST 1.1, Investigator's decision to discontinue treatment, the patient withdraws consent, is lost to follow-up, or Institution decides to terminate the trial. Patients with PD per RECIST 1.1 but with otherwise stable or improved performance and clinical status may continue to be treated in the event of a perceived benefit per Investigator; see Section "Treatment beyond progression". Patients with a partial response (PR) or stable disease (SD) will continue to receive treatment until achievement of a confirmed complete response (CR), disease progression, or intolerance to therapy. It is at the discretion of the Investigator to continue treating patients with a confirmed CR.