Triple Negative Breast CancerPhase 1/2NCT06926920
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
A Phase 1/2 study testing Sacituzumab Govitecan-hziy (SG) in people with Triple Negative Breast Cancer, run by Gilead Sciences at 16 sites in 3 countries.
Trial summary
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Sacituzumab Govitecan-hziy (SG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 30 Apr 2025to Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.
- Histologically or cytologically locally confirmed TNBC.
- Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease.
- Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.
- Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positive score (CPS) < 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay. Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received an anti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-PD-(L)1 agent. due to a comorbidity.
- Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status.
Show all 12Show fewer
- During Phase 1 safety run-in, individuals must be UGT1A1 wild-type.
- After Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible.
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate hematologic counts within 2 weeks prior to enrollment.
- Adequate hepatic and renal function.
Who cannot join
- Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.
- Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
- Note: Other protocol defined Inclusion/Exclusion criteria will apply.
Trial locations and contacts
16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
16 sites in 3 countries
United States9 sites, 9 recruiting
- Recruiting
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322
- Recruiting
Texas Oncology - DFW
Dallas, Texas, 75246
- Recruiting
West Cancer Centre
Germantown, Tennessee, 38138
- Recruiting
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California, 90017
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
- Recruiting
Siteman Cancer Center
St Louis, Missouri, 63110
- Recruiting
The University of Kansas Hospital
Westwood, Kansas, 66205
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Not yet recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
Australia3 sites, 3 recruiting
- Recruiting
Sunshine Coast University Private Hospital
Birtinya, Queensland, 4575
- Recruiting
St. Vincent's Hospital - Kinghorn Cancer Center
Darlinghurst, New South Wales, 2010
- Recruiting
John Flynn Private Hospital
Tugun, Queensland, 4224
About this study
Official title: A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC).
The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).
Read the detailed description
Phase 1 of this study will evaluate the preliminary safety, tolerability, pharmacokinetics (PK), and efficacy of SG. Phase 2 expansion of this study will further evaluate the safety, efficacy, and PK of SG.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Sacituzumab Govitecan-hziy (SG)
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan-hziy (SG)Drug
Also called GS-0132, Trodelvy
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met. Receives: Drug: Sacituzumab Govitecan-hziy (SG) |
| Phase 2: Expansion | Experimental | Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met. Receives: Drug: Sacituzumab Govitecan-hziy (SG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Measured: First dose up to 28 days
Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs)
Measured: First dose up to 30 days post last dose (Up to 3 years)
Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities
Measured: First dose up to 30 days post last dose (Up to 3 years).
Phases 1 and 2: Percentages of Participants Experiencing AEs Leading to Dose Reductions, Dose Interruptions, and Treatment Discontinuations
Measured: First dose up to 30 days post last dose (Up to 3 years).
Phases 1 and 2: Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: Up to 9 months
Phase 2: Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first SG dose until the date of progressive disease (PD) as assessed by the investigator according to RECIST Version 1.1, or death from any cause, whichever occurs first.
Measured: Up to 9 months
Secondary outcomes (4)
Phases 1 and 2: Serum Concentrations of SG
Measured: Up to End of Treatment (3 years)
Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG
Measured: First dose up to 30 days post last dose (Up to 3 years).
Phase 2: Duration of Response (DOR)
DOR is defined as the time from the first documentation of CR or PR to the first documentation of PD as assessed by the investigator according to RECIST Version 1.1, or death from any cause, whichever occurs first.
Measured: First dose up to 30 days post last dose (Up to 3 years).
Phase 2: Disease Control Rate (DCR)
DCR is defined as the proportion of participants who achieve CR, PR, or stable disease as assessed by the investigator according to RECIST Version 1.1.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start30 Apr 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- NCT06926920
- Sponsor's protocol ID
- GS-US-576-7321
- Other IDs
- 2024-519124-25, 2024-519124-25
- Status last verified
- Jan 2026
- First submitted
- 8 Apr 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06926920
- Acronym / sponsor ID
- GS-US-576-7321
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
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) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC).
The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).
Detailed description
Phase 1 of this study will evaluate the preliminary safety, tolerability, pharmacokinetics (PK), and efficacy of SG. Phase 2 expansion of this study will further evaluate the safety, efficacy, and PK of SG.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Drug: Sacituzumab Govitecan-hziy (SG)Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met. |
| Phase 2: Expansion | Experimental | Drug: Sacituzumab Govitecan-hziy (SG)Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.
- Histologically or cytologically locally confirmed TNBC.
- Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease.
- Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.
- Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positive score (CPS) < 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay. Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received an anti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-PD-(L)1 agent. due to a comorbidity.
Key exclusion criteria (3 listed)
- Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.
- Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
- Note: Other protocol defined Inclusion/Exclusion criteria will 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-hziy (SG)Also: GS-0132, TrodelvyAdministered intravenously | Drug | Phase 1, Phase 2: Expansion |
Primary outcome
Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: First dose up to 28 days
Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs)
Time frame: First dose up to 30 days post last dose (Up to 3 years)
Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities
Time frame: First dose up to 30 days post last dose (Up to 3 years).
Phases 1 and 2: Percentages of Participants Experiencing AEs Leading to Dose Reductions, Dose Interruptions, and Treatment Discontinuations
Time frame: First dose up to 30 days post last dose (Up to 3 years).
Phases 1 and 2: Objective Response Rate (ORR)
Time frame: Up to 9 months
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Phase 2: Progression-Free Survival (PFS)
Time frame: Up to 9 months
PFS is defined as the time from the date of the first SG dose until the date of progressive disease (PD) as assessed by the investigator according to RECIST Version 1.1, or death from any cause, whichever occurs first.
4 secondary outcomes
Phases 1 and 2: Serum Concentrations of SG
Time frame: Up to End of Treatment (3 years)
Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG
Time frame: First dose up to 30 days post last dose (Up to 3 years).
Phase 2: Duration of Response (DOR)
Time frame: First dose up to 30 days post last dose (Up to 3 years).
Phase 2: Disease Control Rate (DCR)
Time frame: Up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- 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.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sacituzumab Govitecan-hziy (SG) in people with Triple Negative Breast Cancer, run by Gilead Sciences at 16 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 12 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, South Korea, Australia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) (time frame: First dose up to 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.