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Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
RecruitingPhase 1
A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Key Inclusion Criteria for all Individuals: * Histologically confirmed advanced or metastatic solid tumor that is measurable or nonmeasurable. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. * Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥1,500/mm\^3, and platelets ≥ 100,000/ μL). * Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation. Key Inclusion Criteria for Individuals with Normal Hepatic Function: * Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase (AST) ≤ 3.0× ULN). Key Inclusion Criteria for Individuals with Moderate Hepatic Function: * Moderate hepatic impairment (1.5 × ULN \< total bilirubin ≤ 3.0 × ULN and any level of AST). * For individuals with hepatic encephalopathy, the condition does not, in the Investigator's opinion, interfere with the individual's ability to provide an appropriate informed consent. Key Exclusion Criteria for all Individuals: * Have poor venous access. * Donated or lost 500mL or more of blood volume (including plasmapheresis) to plans to donate during the study. * Have had a prior anticancer biologic agent within 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 and who have not recovered (i.e., ≤ Grade 1) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible. * Had prior treatment with irinotecan within 4 weeks prior to Day 1. * Have not recovered (i.e., ≤ Grade 1) from AEs due to a previously administered agent. * Have an active second malignancy. * Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking \< 20 mg/day of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability. * Have history of cardiac disease. * Have active chronic inflammatory bowel disease (ulcerative colitis or Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment. * Have active serious infection (Contact medical monitor for clarification). * High-dose systemic corticosteroids (≥20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Check-In. However, inhaled, intranasal, intra-articular, and topical steroids are allowed. * Use of strong inhibitor or inducer of UGT1A1. * Have a known history of Gilbert's disease. Key Exclusion Criteria for Individuals with Normal Hepatic Impairment: * Must have pre-existing condition interfering with hepatic and/or renal function that could interfere with the metabolism and/or excretion of the study drug. Key Exclusion Criteria for Individuals with Moderate Hepatic Impairment: * Had a significant clinical exacerbation of liver disease symptoms within the 2-week period before administration of study drug (i.e., abdominal pain, nausea, vomiting, anorexia, or fever). * Had clinically demonstrable, tense ascites. * Had evidence of acute viral hepatitis within 1 month prior to administration of study drug. * Have evidence of hepatorenal syndrome. * Individuals with transjugular intrahepatic portosystemic shunt (TIPS) placement. * Have active Stage 3 or 4 encephalopathy.
About the study
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.
What is being tested
- Sacituzumab Govitecan-hziy (drug)
Sponsor: Gilead Sciences · Participants: 30 · Started: Apr 6, 2021
Contact the study team
- Gilead Clinical Study Information Center · Phone: 1-833-445-3230 (GILEAD-0)
Official record on ClinicalTrials.gov — NCT04617522
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.