A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sacituzumab Govitecan-hziy (SG).
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Primary outcome measures
- 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]
- Phase 2: Progression-Free Survival (PFS) [Time frame: Up to 9 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Los Angeles Cancer Network (LACN) - Good Sam — Los Angeles
- Winship Cancer Institute - Emory University — Atlanta
- The University of Kansas Hospital — Westwood
- Siteman Cancer Center — St Louis
- West Cancer Centre — Germantown
- SCRI Oncology Partners — Nashville
- Tennessee Oncology, PLLC — Nashville
- Texas Oncology - DFW — Dallas
- … and 1 more center
South Korea · 4 centers
- Seoul National University Hospital — Seoul
- Severance Hospital, Yonsei University Health System — Seoul
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
Australia · 3 centers
- St. Vincent's Hospital - Kinghorn Cancer Center — Darlinghurst
- Sunshine Coast University Private Hospital — Birtinya
- John Flynn Private Hospital — Tugun
Identifiers
NCT: NCT06926920 · GS-US-576-7321 · 2024-519124-25 · 2024-519124-25