Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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.
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