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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06926920
Registration number
NCT06926920
Ethics application status
Date submitted
8/04/2025
Date registered
15/04/2025
Date last updated
16/07/2025
Titles & IDs
Public title
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
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Scientific 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
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Secondary ID [1]
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2024-519124-25
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Secondary ID [2]
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GS-US-576-7321
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab Govitecan-hziy (SG)
Experimental: Phase 1 - Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Experimental: Phase 2: Expansion - Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Treatment: Drugs: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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First dose up to 28 days
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Primary outcome [2]
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Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs)
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Assessment method [2]
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Timepoint [2]
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First dose up to 30 days post last dose (Up to 3 years)
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Primary outcome [3]
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Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities
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Assessment method [3]
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Timepoint [3]
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First dose up to 30 days post last dose (Up to 3 years).
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Primary outcome [4]
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Phases 1 and 2: Percentages of Participants Experiencing AEs Leading to Dose Reductions, Dose Interruptions, and Treatment Discontinuations
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Assessment method [4]
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Timepoint [4]
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First dose up to 30 days post last dose (Up to 3 years).
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Primary outcome [5]
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Phases 1 and 2: Objective Response Rate (ORR)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 9 months
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Primary outcome [6]
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Phase 2: Progression-Free Survival (PFS)
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 9 months
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Secondary outcome [1]
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Phases 1 and 2: Serum Concentrations of SG
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Assessment method [1]
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Timepoint [1]
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Up to End of Treatment (3 years)
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Secondary outcome [2]
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Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG
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Assessment method [2]
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Timepoint [2]
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First dose up to 30 days post last dose (Up to 3 years).
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Secondary outcome [3]
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Phase 2: Duration of Response (DOR)
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Assessment method [3]
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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.
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Timepoint [3]
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First dose up to 30 days post last dose (Up to 3 years).
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Secondary outcome [4]
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Phase 2: Disease Control Rate (DCR)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 9 months
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Eligibility
Key inclusion criteria
Key
* 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.
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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2028
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St. Vincent's Hospital - Kinghorn Cancer Center - Darlinghurst
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Tennessee
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Country [3]
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Korea, Republic of
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State/province [3]
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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). 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).
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Trial website
https://clinicaltrials.gov/study/NCT06926920
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gilead Clinical Study Information Center
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Address
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Country
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Phone
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1-833-445-3230 (GILEAD-0)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06926920
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