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

PHASE1PHASE2RECRUITING

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).

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.
  2. Histologically or cytologically locally confirmed TNBC.
  3. 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.
  4. Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.
  5. 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.
  6. Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status.
  7. During Phase 1 safety run-in, individuals must be UGT1A1 wild-type.
  8. After Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible.
  9. Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria.
  10. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  11. Adequate hematologic counts within 2 weeks prior to enrollment.
  12. Adequate hepatic and renal function.

Exclusion criteria

  1. Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.
  2. Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1PHASE2

trial

Study ID

NCT06926920

Intervention or treatment

DRUG: Sacituzumab Govitecan-hziy (SG)

Conditions

  • Triple Negative Breast Cancer

  • Condition: Triple Negative Breast Cancer

  • DRUG: Sacituzumab Govitecan-hziy (SG)

  • Darlinghurst, New South Wales, Australia and more

  • Sponsor: Gilead Sciences

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

St. Vincent's Hospital - Kinghorn Cancer Center

Select from list below to view details:

  • St. Vincent's Hospital - Kinghorn Cancer Center

    Darlinghurst, New South Wales, Australia

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, Australia

  • John Flynn Private Hospital

    Tugun, Queensland, Australia

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Who is running the clinical trial?

GS

Gilead Sciences

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Phase 1
  • Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Drug: Sacituzumab Govitecan-hziy (SG)
    EXPERIMENTAL: Phase 2: Expansion
    • Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
    Drug: Sacituzumab Govitecan-hziy (SG)

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)Not SpecifiedFirst dose up to 28 days
      Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs)Not SpecifiedFirst dose up to 30 days post last dose (Up to 3 years)
      Phases 1 and 2: Percentages of Participants Experiencing Laboratory AbnormalitiesNot SpecifiedFirst 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 DiscontinuationsNot SpecifiedFirst 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 Outcome

      MeasureDescriptionTime Frame
      Phases 1 and 2: Serum Concentrations of SGNot SpecifiedUp to End of Treatment (3 years)
      Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SGNot SpecifiedFirst dose up to 30 days post last dose (Up to 3 years).
      Phase 2: Duration of Response (DOR)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.First dose up to 30 days post last dose (Up to 3 years).
      Phase 2: Disease Control Rate (DCR)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.Up to 9 months
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

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

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