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

NCT04617522 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: IMMU-132-152022-501508-82
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 13

Brief Summary

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.

Conditions

Liver Failure; Advanced or Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (6)

• 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)

• Percentage of Participants Experiencing Any Clinically Significant Laboratory Abnormalities

  First dose date up to Day 38

• 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

Study Arms (2)

Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

EXPERIMENTAL

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

Advanced or Metastatic Solid Tumor and Normal Liver function

EXPERIMENTAL

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

Interventions

Sacituzumab Govitecan-hziy DRUG

Administered intravenously

Also known as: IMMU-132, GS-0132

Advanced or Metastatic Solid Tumor and Moderate Liver Impairment; Advanced or Metastatic Solid Tumor and Normal Liver function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (13)

Pacific Shores Medical Group

Long Beach, California, 90813, United States

SUSPENDED

Christiana Care Health Services

Newark, Delaware, 19713, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

NEXT Austin

Austin, Texas, 78758, United States

WITHDRAWN

Oncology Consultants, P.A.

Houston, Texas, 77030, United States

RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Texas Liver Institute

San Antonio, Texas, 78215, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

Institut Bergonie Medical Oncology

Bordeaux, 33000, France

RECRUITING

Centre Leon Berard

Lyon, 69373, France

RECRUITING

Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain

Saint-Herblain, France

RECRUITING

Institut Català d'Oncologia - L'Hospitalet de Llobregat

Barcelona, 08908, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 21372224 BACKGROUND

• 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.

  PMID: 25915780 BACKGROUND

• 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.

  PMID: 28069724 BACKGROUND

• 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.

  PMID: 26101915 BACKGROUND

• Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.

  PMID: 1244564 BACKGROUND

• 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.

  PMID: 35728046 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Neoplasm Metastasis; Liver Failure

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 5, 2020
• Study Start: April 6, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); FR (3); ES (2)