- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04617522
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
Conditions
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
- Name: Gilead Clinical Study Information Center
- Phone Number: 1-833-445-3230 (GILEAD-0)
- Email: GileadClinicalTrials@gilead.com
Study Locations
-
-
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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
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Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland
-
-
Texas
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Austin, Texas, United States, 78758
- Withdrawn
- NEXT Austin
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Houston, Texas, United States, 77030
- Recruiting
- Oncology Consultants, P.A.
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Houston, Texas, United States, 77030
- Recruiting
- The University of Texas M.D. Anderson Cancer Center
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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:
|
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:
|
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
|
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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.
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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
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Day 1 (Predose) and Day 22
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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
- 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.
- 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. Erratum In: Oncotarget. 2020 Mar 10;11(10):942.
- 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.
Helpful Links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMMU-132-15
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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