Actively Recruiting
Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy
Led by Henry Ford Health System · Updated on 2025-12-19
20
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
Sponsors
H
Henry Ford Health System
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years or older able to give written informed consent
- Histologically or cytologically confirmed metastatic adenocarcinoma of gastrointestinal origin including gastroesophageal, colorectal, and pancreaticobiliary cancers that have failed standard therapy
- Adequate blood counts without transfusions or growth factors within 2 weeks before starting study drug (hemoglobin 63 9 g/dL, ANC 63 1500/mm3, platelets 63 100,000/bcL)
- Adequate liver function (bilirubin 64 1.5x ULN, AST and ALT 64 2.5x ULN or 64 5x ULN if liver metastases, serum albumin > 3 g/dL)
- Adequate kidney function (creatinine clearance 63 30 mL/min by Cockcroft-Gault equation)
- Male and female patients of childbearing potential must agree to use specified contraception methods during and after the study as described
- Females using hormonal contraceptives must be on a stable dose for at least 28 days before dosing and continue use during and after study drug
- Willing and able to comply with study requirements and restrictions
You will not qualify if you...
- Positive pregnancy test or breastfeeding women
- Known allergy to study drugs or their components
- Current use or recent use of prohibited medications as listed in the protocol
- Prior anticancer biologic agents within 4 weeks or chemotherapy, targeted, or radiation therapy within 2 weeks before enrollment without recovery from adverse events (except neuropathy or alopecia)
- Previous treatment with topoisomerase 1 inhibitors
- Active second cancer except for certain treated tumors with low recurrence risk
- Unstable brain metastases; stable brain metastases allowed with conditions
- Recent serious cardiac events or certain cardiac conditions
- Active inflammatory bowel disease or gastrointestinal perforation within 6 months
- Active serious infection requiring antibiotics
- Known HIV infection with detectable viral load or taking drugs affecting SN-38 metabolism
- Active hepatitis B or C infection confirmed by viral load testing
- Other medical or psychiatric conditions that may interfere with study participation or safety
- Use of other investigational drugs within 28 days or 5 half-lives before first study drug dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henry Ford Cancer-Detroit
Detroit, Michigan, United States, 48201
Actively Recruiting
Research Team
M
Maria Diab, MD
CONTACT
M
Meghan Gauronskas, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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