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NCT Number: NCT06926920

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

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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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St. Vincent's Hospital - Kinghorn Cancer Center, Darlinghurst, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sacituzumab Govitecan-hziy (SG)

Drug

Administered intravenously

Other names: GS-0132, Trodelvy

Primary outcomes

  1. Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    Time frame: First dose up to 28 days

  2. 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)

  3. 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).

  4. 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).

  5. Phases 1 and 2: Objective Response Rate (ORR)

    Time frame: 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.

  6. Phase 2: Progression-Free Survival (PFS)

    Time frame: 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.

Secondary outcomes

  1. Phases 1 and 2: Serum Concentrations of SG

    Time frame: Up to End of Treatment (3 years)

  2. 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).

  3. Phase 2: Duration of Response (DOR)

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

    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.

  4. Phase 2: Disease Control Rate (DCR)

    Time frame: Up to 9 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gilead Clinical Study Information Center

CONTACT

[email protected]

1-833-445-3230 (GILEAD-0)

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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