Evaluating sacituzumab govitecan for advanced solid tumors in patients with liver impairment

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

This study is testing a new cancer treatment called sacituzumab govitecan to see if it's safe and effective for people with advanced tumors who also have liver problems.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gilead Sciences (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, prednisone, sacituzumab
• Locations: 13 sites (Long Beach, California and 12 other locations)
• Trial ID: NCT04617522 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and appropriate dosing of sacituzumab govitecan-hziy in patients who have advanced or metastatic solid tumors and moderate liver impairment. Participants will be monitored for their response to the treatment and any potential side effects. The study includes individuals with varying levels of liver function, allowing researchers to gather data on how the drug performs in this specific population. The trial is designed to provide insights that could inform future treatment options for patients with similar conditions.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed advanced or metastatic solid tumors and moderate liver impairment.

Not a fit: Patients with severe liver impairment or those with other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who also have liver impairment.

How similar studies have performed: While there have been studies on sacituzumab govitecan in other populations, this specific focus on patients with liver impairment is relatively novel.

Eligibility criteria

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:

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

Key Inclusion Criteria for Individuals with Moderate Hepatic Function:

* 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.

Key Exclusion Criteria for all Individuals:

* 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.

Key Exclusion Criteria for Individuals with Normal Hepatic Impairment:

* 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.

Key Exclusion Criteria for Individuals with Moderate Hepatic Impairment:

* 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.

Where this trial is running

Long Beach, California and 12 other locations

• Pacific Shores Medical Group — Long Beach, California, United States (Suspended)
• Christiana Care Health Services — Newark, Delaware, United States (Recruiting)
• University of Maryland — Baltimore, Maryland, United States (Recruiting)
• NEXT Austin — Austin, Texas, United States (Withdrawn)
• Oncology Consultants, P.A. — Houston, Texas, United States (Recruiting)
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Texas Liver Institute — San Antonio, Texas, United States (Recruiting)
• NEXT Oncology — San Antonio, Texas, United States (Recruiting)
• Institut Bergonie Medical Oncology — Bordeaux, France (Recruiting)
• Centre Leon Berard — Lyon, France (Recruiting)
• Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain — Saint-Herblain, France (Recruiting)
• Institut Català d'Oncologia - L'Hospitalet de Llobregat — Barcelona, Spain (Recruiting)
• Hospital Universitario Virgen del Rocío — Seville, Spain (Recruiting)

Study contacts

• Study coordinator: Gilead Clinical Study Information Center

Conditions Advanced or Metastatic Solid Tumor; Liver Failure