study of sacituzumab govitecan in participants with advanced or metastatic solid tumor and moderate liver impairment

Conditions: Advanced or Metastatic Solid Tumor; Liver Failure

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 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.