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 (Jun 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
Treatments studied
Targeted therapy
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 →Frequently asked questions
Is NCT04617522 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anticancer biologic agent, chemotherapy, targeted small molecule therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify