RecruitingPhase 1NCT06065371

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

Sponsor

Henry Ford Health System

Enrollment

20 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Gastrointestinal Cancer

Summary

This is a Phase I study to evaluate the safety and tolerability of sacituzumab govitecan in combination with capecitabine for advanced gastrointestinal cancers after progression on standard therapy, and to assess correlation of outcomes with the biomarker Trop-2.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of two drugs — sacituzumab govitecan (an antibody that delivers chemotherapy directly to cancer cells) and capecitabine (an oral chemotherapy) — for people with advanced gastrointestinal cancers, including stomach, colorectal, and pancreatic/bile duct cancers, that have stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older with a confirmed advanced gastrointestinal cancer (gastroesophageal, colorectal, or pancreaticobiliary) - Your cancer has progressed after standard treatment - Your blood counts, liver, and kidney function meet minimum thresholds - You can provide informed consent **You may NOT be eligible if...** - Your cancer has not yet been treated with standard therapies - Your organ function (blood, liver, kidneys) is significantly impaired - You require blood transfusions or growth factor support to maintain blood counts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

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.

DRUGSacituzumab 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.