RecruitingPhase 1NCT04617522

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

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


Sponsor

Gilead Sciences

Enrollment

30 participants

Start Date

Apr 6, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the cancer drug sacituzumab govitecan (an antibody-drug combination that targets cancer cells) in people with advanced or metastatic solid tumors who also have moderate liver impairment. The goal is to understand how the drug behaves and what doses are safe when the liver is not functioning normally. **You may be eligible if...** - You have a confirmed advanced or metastatic solid tumor - You are in reasonably good health overall (ECOG 0–2) - Your blood counts are adequate without recent transfusions - Your kidney function is at least minimally adequate - You either have normal liver function OR have moderate liver impairment **You may NOT be eligible if...** - You have severe liver impairment - Your blood counts, kidney function, or overall health are too poor - You are pregnant or breastfeeding - You have had severe prior reactions to similar drugs (irinotecan-based therapies) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan-hziy

Administered intravenously


Locations(13)

Pacific Shores Medical Group

Long Beach, California, United States

Christiana Care Health Services

Newark, Delaware, United States

University of Maryland

Baltimore, Maryland, United States

NEXT Austin

Austin, Texas, United States

Oncology Consultants, P.A.

Houston, Texas, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Texas Liver Institute

San Antonio, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Institut Bergonie Medical Oncology

Bordeaux, France

Centre Leon Berard

Lyon, France

Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain

Saint-Herblain, France

Institut Català d'Oncologia - L'Hospitalet de Llobregat

Barcelona, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04617522


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