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Cancer drug Trodelvy's Long-Term safety checked in small study

NCT ID NCT04319198

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of the drug sacituzumab govitecan (Trodelvy) in 25 people with metastatic solid tumors who were already benefiting from the treatment. Participants continued to receive the drug intravenously, and researchers tracked any side effects or lab abnormalities. The goal was to see how safe the drug is over a longer period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sacituzumab govitecan (Trodelvy)
What this could lead to
If successful, this study could confirm that sacituzumab govitecan is safe for long-term use in people with metastatic solid tumors, supporting its continued use as a treatment option.
What could go wrong
This is a small, completed safety study with only 25 participants, so results may not apply to everyone. The drug can cause side effects, and the study does not test whether it works better than other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

25 people

The number who actually took part.

Started

Aug 2020

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study. * Continuing to receive clinical benefit from sacituzumab govitecan-hziy therapy. Key Exclusion Criteria: * Females who are pregnant or lactating. * Initiated therapy with another cancer therapeutic agent since receiving last dose of study drug on the parent study in which they participated. * Experienced a toxicity from sacituzumab govitecan-hziy that resulted in permanent discontinuation of therapy. * Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic solid tumors

Contacts and locations

Locations

  • Baptist Health - Miami Cancer Institute

    Miami, Florida, 33176, United States

  • CHU UCL NAMUR - Sainte Elisabeth

    Namur, 5000, Belgium

  • Centre Leon Berard

    Lyon, 69373, France

  • Christiana Care Health Services, Christiana Hospital

    Newark, Delaware, 19718, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33905, United States

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005, United States

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Claudius Regaud

    Toulouse, 31059, France

  • Institut Jules Bordet

    Brussels, 1000, Belgium

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • New York Cancer & Blood Specialists - Setauket Medical Oncology

    Port Jefferson, New York, 11776, United States

  • Next Oncology

    Austin, Texas, 78758, United States

  • Oncology Consultants,P.A.

    Houston, Texas, 77024, United States

  • Rocky Mountain Cancer Center

    Aurora, Colorado, 80012, United States

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

    Houston, Texas, 77030, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of MD Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

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Other studies related to the condition(s) this trial covers.