OncoMatch/Clinical Trials/NCT04617522
Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Is NCT04617522 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Sacituzumab Govitecan-hziy for advanced or metastatic solid tumor.
Treatment: Sacituzumab Govitecan-hziy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Required: Stage IV
advanced or metastatic solid tumor that is measurable or nonmeasurable
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anticancer biologic agent
prior anticancer biologic agent within 4 weeks prior to Day 1
Cannot have received: chemotherapy
prior chemotherapy ... within 2 weeks prior to Day 1
Cannot have received: targeted small molecule therapy
prior ... targeted small molecule therapy ... within 2 weeks prior to Day 1
Cannot have received: radiation therapy
prior ... radiation therapy within 2 weeks prior to Day 1
Cannot have received: topoisomerase inhibitor (irinotecan)
prior treatment with irinotecan within 4 weeks prior to Day 1
Lab requirements
Blood counts
Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, ANC ≥1,500/mm^3, and platelets ≥ 100,000/ μL)
Kidney function
Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation
Liver function
Normal hepatic function (total bilirubin ≤ ULN and AST ≤ 3.0× ULN) for normal hepatic function cohort; Moderate hepatic impairment (1.5 × ULN < total bilirubin ≤ 3.0 × ULN and any level of AST) for moderate hepatic impairment cohort
Adequate hematologic counts ... Creatinine clearance ≥ 30 mL/min ... Normal hepatic function ... Moderate hepatic impairment ...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Pacific Shores Medical Group · Long Beach, California
- Christiana Care Health Services · Newark, Delaware
- University of Maryland · Baltimore, Maryland
- NEXT Austin · Austin, Texas
- Oncology Consultants, P.A. · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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