Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan-hziy in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to identify the safe starting dose of sacituzumab govitecan-hziy, assess the number of participants with antibodies against sacituzumab govitecan-hziy, and evaluate the pharmacokinetics (PK) of sacituzumab govitecan-hziy, free SN-38, SN-38 glucuronide (SN-38G), total SN-38, in participants with solid tumor and moderate hepatic impairment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences; Immunomedics, Inc.

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 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