A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer (NCT06926920) — South Korea Trial Details

Condition(s) studied

Triple Negative Breast Cancer

Investigational drug(s) / intervention(s)

Sacituzumab Govitecan-hziy (SG): Administered intravenously

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Key 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. 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.

Primary outcome measure(s)

Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) — First dose up to 28 days
Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs) — First dose up to 30 days post last dose (Up to 3 years)
Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities — 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 — First dose up to 30 days post last dose (Up to 3 years).
Phases 1 and 2: Objective Response Rate (ORR) — 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) — 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.

Trial sites (16)

Facility	City	Region	Status
Los Angeles Cancer Network (LACN) - Good Sam	Los Angeles	California	Recruiting
Winship Cancer Institute - Emory University	Atlanta	Georgia	Recruiting
The University of Kansas Hospital	Westwood	Kansas	Recruiting
Siteman Cancer Center	St Louis	Missouri	Recruiting
West Cancer Centre	Germantown	Tennessee	Recruiting
SCRI Oncology Partners	Nashville	Tennessee	Recruiting
Tennessee Oncology, PLLC	Nashville	Tennessee	Recruiting
Texas Oncology - DFW	Dallas	Texas	Recruiting
Virginia Oncology Associates	Norfolk	Virginia	Recruiting
St. Vincent's Hospital - Kinghorn Cancer Center	Darlinghurst	New South Wales	Recruiting
Sunshine Coast University Private Hospital	Birtinya	Queensland	Recruiting
John Flynn Private Hospital	Tugun	Queensland	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Severance Hospital, Yonsei University Health System	Seoul	South Korea	Not Yet Recruiting
Asan Medical Center	Seoul	South Korea	Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting

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