Actively Recruiting
Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Led by Gilead Sciences · Updated on 2026-02-11
30
Participants Needed
13
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.
CONDITIONS
Official Title
Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced or metastatic solid tumor, measurable or nonmeasurable
- ECOG performance status score of 0, 1, or 2
- Adequate blood counts without transfusion or growth factor support within 2 weeks before starting study drug (hemoglobin 9 g/dL, ANC 1500/mm^3, platelets 100,000/bcL)
- Creatinine clearance 30 mL/min by Cockcroft-Gault equation
- Normal hepatic function (total bilirubin ULN and AST 3.0�d7 ULN) for normal hepatic function group
- Moderate hepatic impairment (total bilirubin > 1.5�d7 ULN and 3.0�d7 ULN and any AST level) for moderate hepatic function group
- For hepatic encephalopathy, ability to provide informed consent as judged by Investigator
You will not qualify if you...
- Poor venous access
- Donated or lost 500 mL or more blood volume or plans to donate during study
- Prior anticancer biologic agent within 4 weeks before Day 1 or chemotherapy, targeted therapy, or radiation within 2 weeks without recovery to Grade 1 adverse events
- Prior irinotecan treatment within 4 weeks before Day 1
- Not recovered from adverse events of previous treatment
- Active second malignancy
- Known active CNS metastases or carcinomatous meningitis (except stable brain metastases under certain conditions)
- History of cardiac disease
- Active chronic inflammatory bowel disease or GI perforation within 6 months
- Active serious infection
- High-dose systemic corticosteroids ( 20 mg prednisone or equivalent) within 2 weeks before Check-In
- Use of strong UGT1A1 inhibitors or inducers
- Known Gilbert's disease
- Pre-existing conditions interfering with liver or kidney function affecting drug metabolism for normal hepatic function group
- Recent clinical exacerbation of liver disease symptoms within 2 weeks for moderate hepatic function group
- Clinically demonstrable tense ascites
- Evidence of acute viral hepatitis within 1 month
- Evidence of hepatorenal syndrome
- Presence of transjugular intrahepatic portosystemic shunt (TIPS)
- Active Stage 3 or 4 hepatic encephalopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Suspended
2
Christiana Care Health Services
Newark, Delaware, United States, 19713
Actively Recruiting
3
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
NEXT Austin
Austin, Texas, United States, 78758
Withdrawn
5
Oncology Consultants, P.A.
Houston, Texas, United States, 77030
Actively Recruiting
6
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
8
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
9
Institut Bergonie Medical Oncology
Bordeaux, France, 33000
Actively Recruiting
10
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
11
Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain
Saint-Herblain, France
Actively Recruiting
12
Institut Català d'Oncologia - L'Hospitalet de Llobregat
Barcelona, Spain, 08908
Actively Recruiting
13
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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