Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy
NCT ID: NCT04319198
Last Updated: 2025-09-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
25 participants
INTERVENTIONAL
2020-08-04
2024-10-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
NCT06167317
Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments
NCT04058756
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies
NCT05006794
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
NCT06276491
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
NCT05836324
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)
All participants who previously received SG in the parent study (IMMU-132-01) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Sacituzumab Govitecan-hiy
Administered intravenously
Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)
All participants who previously received SG in the parent study (IMMU-132-05) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Sacituzumab Govitecan-hiy
Administered intravenously
Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15)
All participants who previously received SG in the parent study (IMMU-132-15) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Sacituzumab Govitecan-hiy
Administered intravenously
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sacituzumab Govitecan-hiy
Administered intravenously
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Continuing to receive clinical benefit from sacituzumab govitecan-hziy therapy.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Francisco
San Francisco, California, United States
Rocky Mountain Cancer Center
Aurora, Colorado, United States
Christiana Care Health Services, Christiana Hospital
Newark, Delaware, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
Baptist Health - Miami Cancer Institute
Miami, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of MD Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
New York Cancer & Blood Specialists - Setauket Medical Oncology
Port Jefferson, New York, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Next Oncology
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
NEXT Oncology
San Antonio, Texas, United States
Institut Jules Bordet
Brussels, , Belgium
CHU UCL NAMUR - Sainte Elisabeth
Namur, , Belgium
Institut Bergonie
Bordeaux, , France
Centre Leon Berard
Lyon, , France
Institut Claudius Regaud
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Gilead Clinical Trials Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-505336-34
Identifier Type: OTHER
Identifier Source: secondary_id
IMMU-132-14
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.