Advanced or Metastatic Solid Tumor, Liver Failure
Conditions
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.
Interventions
DRUGSacituzumab Govitecan-hziy
Administered intravenously
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Days 1 and 8 | 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. |
| PK Parameter: AUC 0-168 of Free SN-38 and Sacituzumab Govitecan-hziy | Days 1 and 8 | 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. |
| Percentage of Participants who Develop Anti-Sacituzumab Govitecan-hziy Antibodies | Day 1 (Predose) and Day 22 | — |
Countries
France, Italy, Spain, United States
Contacts
CONTACTGilead Clinical Study Information Center
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed