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

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
• Conditions: Liver Failure; Advanced or Metastatic Solid Tumor
• Intervention / Treatment: Drug: Sacituzumab Govitecan-hziy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gilead Clinical Study Information Center; Phone Number: 1-833-445-3230 (GILEAD-0); Email: GileadClinicalTrials@gilead.com

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • Institut Bergonie Medical Oncology
  • Lyon, France, 69373
    • Recruiting
    • Centre Léon Bérard
  • Saint-Herblain, France
    • Recruiting
    • Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain
• Italy
  • Milan, Italy, 20141
    • Recruiting
    • Instituto Europeo di Oncologia
  • Naples, Italy, 80131
    • Recruiting
    • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
• Spain
  • Barcelona, Spain, 08908
    • Recruiting
    • Institut Català d'Oncologia - L'Hospitalet de Llobregat
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
• United States
  • 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      • Withdrawn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, 78215
      • Recruiting
      • Texas Liver Institute
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT Oncology

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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).	Drug: Sacituzumab Govitecan-hziy; 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).	Drug: Sacituzumab Govitecan-hziy; 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 Any Clinically Significant Laboratory Abnormalities		First dose date up to Day 38
Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) and Serious AEs		First 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)
Pharmacokinetic (PK) Parameter: Cmax of Free SN-38 and Sacituzumab Govitecan-hziy	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.	Days 1 and 8
PK Parameter: AUC 0-168 of Free SN-38 and Sacituzumab Govitecan-hziy	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.	Days 1 and 8
Percentage of Participants who Develop Anti-Sacituzumab Govitecan-hziy Antibodies		Day 1 (Predose) and Day 22

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Arrojo R, Liu D, Rossi EA, Chang CH, Goldenberg DM. Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. Bioconjug Chem. 2015 May 20;26(5):919-31. doi: 10.1021/acs.bioconjchem.5b00223. Epub 2015 May 8.
• Cardillo TM, Sharkey RM, Rossi DL, Arrojo R, Mostafa AA, Goldenberg DM. Synthetic Lethality Exploitation by an Anti-Trop-2-SN-38 Antibody-Drug Conjugate, IMMU-132, Plus PARP Inhibitors in BRCA1/2-wild-type Triple-Negative Breast Cancer. Clin Cancer Res. 2017 Jul 1;23(13):3405-3415. doi: 10.1158/1078-0432.CCR-16-2401. Epub 2017 Jan 9.
• Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Goldenberg DM. Humanized anti-Trop-2 IgG-SN-38 conjugate for effective treatment of diverse epithelial cancers: preclinical studies in human cancer xenograft models and monkeys. Clin Cancer Res. 2011 May 15;17(10):3157-69. doi: 10.1158/1078-0432.CCR-10-2939. Epub 2011 Mar 3.
• Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
• Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.
• Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Oncotarget. 2015 Sep 8;6(26):22496-512. doi: 10.18632/oncotarget.4318.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

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): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Hepatic Insufficiency; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Liver Failure; Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; sacituzumab govitecan
• Other Study ID Numbers: IMMU-132-15; 2022-501508-82 (Other Identifier: EU CT Number)

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