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

November 29, 2023 updated by: Gilead Sciences

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Lyon, France, 69373
        • Recruiting
        • Centre Leon Berard
    • California
      • Long Beach, California, United States, 90813
        • Suspended
        • Pacific Shores Medical Group
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Christiana Care Health Services
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
    • Texas
      • Austin, Texas, United States, 78758
        • Withdrawn
        • NEXT Austin
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants, P.A.
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M.D. Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Participants with advanced solid tumor and moderate hepatic impairment will receive an escalating dose of sacituzumab govitecan-hziy on Days 1 and 8. The dose-escalation plan will start at 5 mg/kg and escalate to 7.5 mg/kg, and finally 10 mg/kg, if deemed to be safe. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
Experimental: Advanced or Metastatic Solid Tumor and Normal Liver function
Participants with advanced or metastatic solid tumor and normal hepatic function will receive sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs)
Time Frame: First dose date up to Day 38
First dose date up to Day 38
Percentage of Participants Experiencing Any Clinically Significant Laboratory Abnormalities
Time Frame: First dose date up to Day 38
First dose date up to Day 38
PK Parameter: Cmax of Free SN-38, SN-38 Glucuronide, Total SN-38, and Sacituzumab Govitecan-hziy
Time Frame: Days 1 and 8
Cmax will be determined for 4 analytes: Free SN-38, SN-38 glucuronide, Total 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.
Days 1 and 8
PK Parameter: AUC_last of Free SN-38, SN-38 Glucuronide, Total SN-38, and Sacituzumab Govitecan-hziy
Time Frame: Days 1 and 8
AUC_last will be determined for 4 analytes: Free SN-38, SN-38 glucuronide, Total SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC_last is defined as area under the serum concentration-time curve from time 0 to time of the last quantifiable concentration of the 4 analytes.
Days 1 and 8
PK Parameter: AUC_0-168 of Free SN-38, SN-38 Glucuronide, Total SN-38, and Sacituzumab Govitecan-hziy
Time Frame: Days 1 and 8
AUC_0-168 will be determined for 4 analytes: Free SN-38, SN-38 glucuronide, Total 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.
Days 1 and 8
Percentage of Participants who Develop Positive Anti-Sacituzumab Govitecan-hziy Antibodies
Time Frame: Day 1 (Predose) and Day 22
Day 1 (Predose) and Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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