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
Gilead Sciences
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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: * Norm…
Interventions
- DrugSacituzumab Govitecan-hziy
Administered intravenously
Locations (13)
- Pacific Shores Medical GroupLong Beach, California
- Christiana Care Health ServicesNewark, Delaware
- University of MarylandBaltimore, Maryland
- NEXT AustinAustin, Texas
- Oncology Consultants, P.A.Houston, Texas
- The University of Texas M.D. Anderson Cancer CenterHouston, Texas