Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy

Last updated: September 12, 2025
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

4

Condition

Neoplasms

Treatment

Sacituzumab Govitecan-hiy

Clinical Study ID

NCT04319198
IMMU-132-14
2023-505336-34
2019-004868-22
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and how safe it is in participants with metastatic cancer (cancer that has spread).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previouslyImmunomedics)-sponsored parent study.

  • Continuing to receive clinical benefit from sacituzumab govitecan-hziy therapy.

Exclusion

Key Exclusion Criteria:

  • Females who are pregnant or lactating.

  • Initiated therapy with another cancer therapeutic agent since receiving last dose ofstudy drug on the parent study in which they participated.

  • Experienced a toxicity from sacituzumab govitecan-hziy that resulted in permanentdiscontinuation of therapy.

  • Have other concurrent medical or psychiatric conditions that, in the Investigator'sopinion, may be likely to confound study interpretation or prevent completion ofstudy procedures and follow-up examinations.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Sacituzumab Govitecan-hiy
Phase: 4
Study Start date:
August 04, 2020
Estimated Completion Date:
October 18, 2024

Study Description

This is a rollover study. Only participants who continue to receive clinical benefit from continuation of SG therapy and are tolerating therapy at the time of enrollment are eligible for this study. Participants enrolled may continue to receive SG at the dose that they were receiving in the Gilead parent study at the time of consenting to participate in this rollover study.

Connect with a study center

  • Institut Jules Bordet

    Brussels 2800866, 1000
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Bruxelles, 1000
    Belgium

    Site Not Available

  • CHU UCL NAMUR - Sainte Elisabeth

    Namur, 5000
    Belgium

    Site Not Available

  • CHU UCL NAMUR - Sainte Elisabeth

    Namur 2790471, 5000
    Belgium

    Site Not Available

  • Institut Bergonie

    Bordeaux 3031582, 33076
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux Cedex, 33076
    France

    Site Not Available

  • Centre Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • Centre Leon Berard

    Lyon 2996944, 69373
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Aurora 5412347, Colorado 5417618 80012
    United States

    Site Not Available

  • Christiana Care Health Services, Christiana Hospital

    Newark, Delaware 19718
    United States

    Site Not Available

  • Christiana Care Health Services, Christiana Hospital

    Newark 4143861, Delaware 4142224 19718
    United States

    Site Not Available

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida 33905
    United States

    Site Not Available

  • Baptist Health - Miami Cancer Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • Florida Cancer Specialists & Research Institute

    Fort Myers 4155995, Florida 4155751 33905
    United States

    Site Not Available

  • Baptist Health - Miami Cancer Institute

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • Illinois Cancer Specialists

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Illinois Cancer Specialists

    Arlington Heights 4883555, Illinois 4896861 60005
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • University of MD Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • University of MD Greenebaum Comprehensive Cancer Center

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Setauket Medical Oncology

    Port Jefferson, New York 11776
    United States

    Site Not Available

  • NY Cancer and Blood Specialists Research Department

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Setauket Medical Oncology

    Port Jefferson 5132013, New York 5128638 11776
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Next Oncology

    Austin, Texas 78758
    United States

    Site Not Available

  • Oncology Consultants,P.A.

    Houston, Texas 77024
    United States

    Site Not Available

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Next Oncology

    Austin 4671654, Texas 4736286 78758
    United States

    Site Not Available

  • Oncology Consultants,P.A.

    Houston 4699066, Texas 4736286 77024
    United States

    Site Not Available

  • The University of Texas M.D. Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

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