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

Must have received: standard therapy

have failed standard therapy

Cannot have received: topoisomerase 1 inhibitor

Have previously received topoisomerase 1 inhibitors.

Cannot have received: anticancer biologic agent

Exception: within 4 weeks prior to enrolment

Have had a prior anticancer biologic agent within 4 weeks prior to enrolment

Cannot have received: chemotherapy, targeted small molecule therapy, or radiation therapy

Exception: within 2 weeks prior to enrollment and have not recovered (i.e., ≥ Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study.

have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (i.e., ≥ Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry.

Cannot have received: investigational drug

Exception: within 28 days or 5 half-lives (whichever is longer) of first dose of study drug

Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.