Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

ConditionsAdvanced or Metastatic Solid Tumor Liver Failure

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorGilead Sciences

About this trial

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

Qualifiers

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.

Disqualifiers

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.