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

ConditionsAdvanced or Metastatic Solid Tumor Liver Failure

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorGilead Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Sacituzumab Govitecan-hziy
Drug
Administered intravenously

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Advanced or Metastatic Solid Tumor and Moderate Liver ImpairmentExperimental treatment 1 intervention

Group B: Advanced or Metastatic Solid Tumor and Normal Liver functionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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.

Time frame

Days 1 and 8