Study Details

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Advanced or Metastatic Solid Tumor, Liver Failure

Gender

N/A

Date

April 2021 - November 2023

Study Type

Interventional

Study Phase

Phase 1

Product

Sacituzumab Govitecan-hziy

Eligibility Information

Inclusion Criteria

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.

Exclusion Criteria

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 2) 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 requiring intravenous antibiotics (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 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 clinical exacerbation of liver disease 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

Locations

Locations (8)

Pacific Shores Medical Group

Long Beach, California, United States, 90813

Christiana Care Health Services

Newark, Delaware, United States, 19713

University of Maryland

Baltimore, Maryland, United States, 21201

NEXT Austin

Austin, Texas, United States, 78758

Oncology Consultants, P.A.

Houston, Texas, United States, 77030

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

NEXT Oncology

San Antonio, Texas, United States, 78229

Centre Leon Berard

Lyon, France, 69373

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

OVERVIEW

PROTOCOL SUMMARY