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Sacituzumab Govitecan for Advanced Solid Tumors with Moderate Liver Impairment

This study is looking at the safety and how much sacituzumab govitecan-hziy (a drug given through a vein) can be given to people with advanced or metastatic (spread) solid tumors who also have moderate liver problems. The main goals are to see how many participants experience side effects, serious side effects, dose-limiting toxicities (side effects that stop you from taking more of the drug), and significant abnormal lab results. You might be able to join if you are 18 or older, have a confirmed advanced or metastatic solid tumor, and meet certain health requirements like good blood counts. The study aims to enroll about 30 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored from the first dose up to Day 38. Dose-limiting toxicities will be assessed up to Day 22 or Day 28, depending on the dosing schedule.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04617522

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Gilead Sciences
~30 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Sacituzumab Govitecan-hziy

At a glance

Recruiting sites
13 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) and Serious AEs
Measured over First dose date up to Day 38
+5 more outcomes measured

Conditions

Advanced or Metastatic Solid Tumor
Liver Failure

Explore related trials

Liver FailureSolid Neoplasm

Where it's being run

15 sites across 7 states
Texas5
France3
Italy2
Spain2
California1
Delaware1
Maryland1

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Center
[email protected]
1-833-445-3230 (GILEAD-0)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase (AST) ≤ 3.0× ULN).
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.

Exclusion

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.
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.
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.

What this trial measures

  • Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) and Serious AEsFirst dose date up to Day 38
  • Percentage of Participants Experiencing Any Dose Limiting Toxicities (DLTs)Up to Day 22 (for participants receiving SG on Day 1); Up to Day 28 (for participants receiving SG on Day 8)
  • Percentage of Participants Experiencing Any Clinically Significant Laboratory AbnormalitiesFirst dose date up to Day 38
  • Pharmacokinetic (PK) Parameter: Cmax of Free SN-38 and Sacituzumab Govitecan-hziyDays 1 and 8

    Cmax will be determined for 2 analytes: Free SN-38 and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. Cmax is defined as the maximum observed concentration obtained directly from the observed concentration-time data.

  • PK Parameter: AUC 0-168 of Free SN-38 and Sacituzumab Govitecan-hziyDays 1 and 8

    AUC 0-168 will be determined for 2 analytes: Free SN-38 and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC0-168 is defined as area under the serum concentration-time curve from time 0 to 168 hours.

  • Percentage of Participants who Develop Anti-Sacituzumab Govitecan-hziy AntibodiesDay 1 (Predose) and Day 22