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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Los Angeles Cancer Network (LACN) - Good Sam
RECRUITING
Los Angeles
Georgia
Winship Cancer Institute - Emory University
RECRUITING
Atlanta
Missouri
Siteman Cancer Center
RECRUITING
St Louis
Tennessee
West Cancer Centre
RECRUITING
Germantown
SCRI Oncology Partners
RECRUITING
Nashville
Tennessee Oncology, PLLC
RECRUITING
Nashville
Texas
Texas Oncology - DFW
RECRUITING
Dallas
Other Locations
Australia
Sunshine Coast University Private Hospital
RECRUITING
Birtinya
St. Vincent's Hospital - Kinghorn Cancer Center
RECRUITING
Darlinghurst
John Flynn Private Hospital
RECRUITING
Tugun
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2028-06
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Gilead Sciences

This content was sourced from clinicaltrials.gov