A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer

NCT06926920 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: GS-US-576-73212024-519124-25
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 16

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).

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (6)

• 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)

  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.

  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.

  Up to 9 months

Secondary Outcomes (4)

• Phases 1 and 2: Serum Concentrations of SG

  Up to End of Treatment (3 years)

• Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG

  First dose up to 30 days post last dose (Up to 3 years).

• Phase 2: Duration of Response (DOR)

  First dose up to 30 days post last dose (Up to 3 years).

• Phase 2: Disease Control Rate (DCR)

  Up to 9 months

Study Arms (2)

Phase 1

EXPERIMENTAL

Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.

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.

Drug: Sacituzumab Govitecan-hziy (SG)

Interventions

Sacituzumab Govitecan-hziy (SG) DRUG

Administered intravenously

Also known as: GS-0132, Trodelvy

Phase 1; Phase 2: Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (16)

Los Angeles Cancer Network (LACN) - Good Sam

Los Angeles, California, 90017, United States

RECRUITING

Winship Cancer Institute - Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

The University of Kansas Hospital

Westwood, Kansas, 66205, United States

RECRUITING

Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

West Cancer Centre

Germantown, Tennessee, 38138, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - DFW

Dallas, Texas, 75246, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

St. Vincent's Hospital - Kinghorn Cancer Center

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Sunshine Coast University Private Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

John Flynn Private Hospital

Tugun, Queensland, 4224, Australia

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 15, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); AU (3); KR (4)