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Capecitabine

Sacituzumab govitecan

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Antimetabolites

The trial has three dose levels. Dose level -1 has capecitabine at 500mg/m2 twice daily taken orally for two weeks on and one week off, plus sacituzumab govitecan at 7.5mg/kg given intravenously on Days 1 and 8. Each cycle is 21 days. Dose level 0 has capecitabine at 500mg/m2 and sacituzumab govitecan at 10mg/kg. Dose level 1 has capecitabine at 825mg/m2 and sacituzumab govitecan at 10mg/kg.

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.

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.

Sacituzumab govetican

Maria Diab, MD

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.

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.

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

Correlation between Trop-2 expression and overall response rates and progression-free and overall survivals

Measure toxicity using National Cancer Information Center (NCIC) criteria v4.0. Measurement

Cross sectional imaging and RECIST criteria

Time from best response measured by RECIST until progression

Survival from starting treatment until progression

Survival from starting treatment until death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy	NCT06065371	Gastrointestina...	Capecitabine Sacituzumab gov...	18 Years -	Henry Ford Health System
Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy	NCT06065371	Gastrointestina...	Capecitabine Sacituzumab gov...	18 Years -	Henry Ford Health System

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