Recruiting
Phase 1

Sacituzumab Govitecan

Sponsor:

Gilead Sciences

Code:

NCT04617522

Conditions

Advanced or Metastatic Solid Tumor

Liver Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab Govitecan-hziy

Study Details

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

Advanced or Metastatic Solid Tumor

Liver Failure

Study ID

NCT04617522

Start date

Apr 6, 2021

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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).

Interventions

Sacituzumab Govitecan-hziy

Administered intravenously

Primary outcome measure

  • Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) and Serious AEs [ Time Frame: First dose date up to Day 38 ]
  • Percentage of Participants Experiencing Any Dose Limiting Toxicities (DLTs) [ Time Frame: 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 [ Time Frame: First dose date up to Day 38 ]
  • Pharmacokinetic (PK) Parameter: Cmax of Free SN-38 and Sacituzumab Govitecan-hziy [ Time Frame: Days 1 and 8 ]
  • PK Parameter: AUC 0-168 of Free SN-38 and Sacituzumab Govitecan-hziy [ Time Frame: Days 1 and 8 ]
  • Percentage of Participants who Develop Anti-Sacituzumab Govitecan-hziy Antibodies [ Time Frame: Day 1 (Predose) and Day 22 ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

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

Locations

Christiana Care Health Services

Recruiting

Newark, Delaware, United States, 19713

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

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

Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Gilead Sciences

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-06-02.