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

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ClinicalTrials.gov Identifier: NCT04617522
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumor Liver Failure Drug: Sacituzumab Govitecan-hziy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to Day 38 ]
  2. Percentage of Participants Experiencing Any Clinically Significant Laboratory Abnormalities [ Time Frame: First dose date up to Day 38 ]
  3. 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.

  4. 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.

  5. 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.

  6. Percentage of Participants who Develop Positive Anti-Sacituzumab Govitecan-hziy Antibodies [ Time Frame: Day 1 (Predose) and Day 22 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04617522


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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United States, California
Pacific Shores Medical Group Suspended
Long Beach, California, United States, 90813
United States, Delaware
Christiana Care Health Services Not yet recruiting
Newark, Delaware, United States, 19713
United States, Texas
NEXT Austin Recruiting
Austin, Texas, United States, 78758
Oncology Consultants, P.A. Recruiting
Houston, Texas, United States, 77030
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04617522    
Other Study ID Numbers: IMMU-132-15
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases