Metastatic Solid TumorsPhase 4NCT04319198
Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy
A Phase 4 study testing Sacituzumab Govitecan-hiy in people with Metastatic Solid Tumors, run by Gilead Sciences at 21 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumors
- What is being tested?
- Sacituzumab Govitecan-hiy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 4 Aug 2020to 18 Oct 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study.
- Continuing to receive clinical benefit from sacituzumab govitecan-hziy therapy.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States16 sites
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Rocky Mountain Cancer Center
Aurora, Colorado, 80012
Next Oncology
Austin, Texas, 78758
University of MD Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33905
Oncology Consultants,P.A.
Houston, Texas, 77024
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Baptist Health - Miami Cancer Institute
Miami, Florida, 33176
Christiana Care Health Services, Christiana Hospital
Newark, Delaware, 19718
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213
New York Cancer & Blood Specialists - Setauket Medical Oncology
Port Jefferson, New York, 11776
NEXT Oncology
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94143
France3 sites
Institut Bergonie
Bordeaux, 33076
Centre Leon Berard
Lyon, 69373
Institut Claudius Regaud
Toulouse, 31059
Belgium2 sites
Institut Jules Bordet
Brussels, 1000
CHU UCL NAMUR - Sainte Elisabeth
Namur, 5000
About this study
Official 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
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).
Read the detailed 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.
- Conditions
- Metastatic Solid Tumors
- Being tested
- Sacituzumab Govitecan-hiy
- Keywords
- ADC, Antibody-Drug Conjugate, Trop-2, SN-38
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan-hiyDrug
Also called IMMU-132, Trodelvy™, GS-0132
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) | Experimental | 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. Receives: Drug: Sacituzumab Govitecan-hiy |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) | Experimental | 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. Receives: Drug: Sacituzumab Govitecan-hiy |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) | Experimental | 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. Receives: Drug: Sacituzumab Govitecan-hiy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Any Adverse Events
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.
Measured: First dose date up to 30 days post last dose (Up to 3.9 years)
Percentage of Participants Experiencing Any Serious Adverse Events
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.
Measured: First dose date up to 30 days post last dose (Up to 3.9 years)
Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities
The percentage of participants experiencing any clinically significant laboratory abnormality was summarized.
Measured: First dose date up to 30 days post last dose (Up to 3.9 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start4 Aug 2020
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319198
- Sponsor's protocol ID
- IMMU-132-14
- Other IDs
- 2023-505336-34, 2023
- Status last verified
- Sep 2025
- First submitted
- 19 Mar 2020
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35728046
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04319198
- Acronym / sponsor ID
- IMMU-132-14
- Conditions
- Metastatic Solid Tumors
- Keywords
- ADC, Antibody-Drug Conjugate, Trop-2, SN-38
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Posted 30 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) | Experimental | Drug: Sacituzumab Govitecan-hiyAll 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-hziy (Parent Study: IMMU-132-05) | Experimental | Drug: Sacituzumab Govitecan-hiyAll 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-hziy (Parent Study: IMMU-132-15) | Experimental | Drug: Sacituzumab Govitecan-hiyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Govitecan-hiyAlso: IMMU-132, Trodelvy™, GS-0132Administered intravenously | Drug | Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01), Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05), Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35728046Kwapisz 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.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sacituzumab Govitecan-hiy in people with Metastatic Solid Tumors, run by Gilead Sciences at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Any Adverse Events (time frame: First dose date up to 30 days post last dose (Up to 3.9 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.