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Completed

NCT Number: NCT04319198

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

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).

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Key information

Conditions

Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut Jules Bordet, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sacituzumab Govitecan-hiy

Drug

Administered intravenously

Other names: IMMU-132, Trodelvy™, GS-0132

Primary outcomes

  1. Percentage of Participants Experiencing Any Adverse Events

    Time frame: First dose date up to 30 days post last dose (Up to 3.9 years)

    An adverse event was defined as any untoward medical occurrence in a participant administered a medicinal product that does not necessarily have a causal relationship with this treatment.

  2. Percentage of Participants Experiencing Any Serious Adverse Events

    Time frame: First dose date up to 30 days post last dose (Up to 3.9 years)

    A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, was fatal (resulting in death), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.

  3. Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities

    Time frame: First dose date up to 30 days post last dose (Up to 3.9 years)

    The percentage of participants experiencing any clinically significant laboratory abnormality was summarized.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

Open-label Rollover Study to Evaluate Long-Term Safety in Subjects With Metastatic Solid Tumors That Are Benefiting From Continuation of Therapy With Sacituzumab Govitecan

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2020
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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