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

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 20, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

May 31, 2026

Conditions
Gastrointestinal Cancer
Interventions
DRUG

Capecitabine

Capecitabine is a fluoropyrimidine that is metabolized to 5-fluorouracil, which inhibits thymidylate synthase. Capecitabine is available in white or off-white tablets with doses of 500mg and 150mg doses. 500mg dose tablets will be used on this trial. Capecitabine will be ordered as a standard of care and provided commercially.

DRUG

Sacituzumab govetican

"Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2-expressing cells and is covalently attached to the topoisomerase I inhibitor SN-38. Sacituzumab govitecan will be provided by Gilead Sciences.~Sacituzumab govitecan for injection, 180 mg and 200 mg, is available as a powder that is to be reconstituted with 20 mL of 0.9% Sodium Chloride Injection prior to intravenous infusion.~Following reconstitution, each single-dose vial of Sacituzumab govitecan results in a concentration of 10mg/mL with pH of 6.5."

Trial Locations (1)

48201

RECRUITING

Henry Ford Cancer-Detroit, Detroit

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Henry Ford Health System

OTHER