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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a different dose and schedule of sacituzumab govitecan (SG) for adults with advanced triple-negative breast cancer. It looks at side effects, whether tumors shrink, and how long people live without their cancer getting worse.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, of any sex assigned at birth, and able to understand and sign a consent form.
  • Triple-negative breast cancer confirmed by a tissue or cell test. The cancer must have spread nearby or to other parts of the body and cannot be removed with surgery.
  • Phase 1: Cancer did not respond to, or came back after, at least one standard chemotherapy or other whole-body treatment for advanced cancer.
  • Phase 2: No past whole-body treatment for advanced cancer.
  • Phase 2: A tumor PD-L1 test score below 10. A score of 10 or higher may qualify if you had certain immune treatments before or after surgery, or cannot receive them because of another health condition.
  • Your UGT1A1 gene type must be known. During the first safety-testing part of Phase 1, it must be the usual type, called wild-type. After that, any type may qualify.
  • Cancer that can be measured on a CT or MRI scan. You must be fully active or able to do light work, with limits only on hard physical activity.
  • Blood cell counts must meet study requirements within 2 weeks before joining. Liver and kidneys must also work well enough.

Who can't join

  • Past treatment with a topoisomerase 1 inhibitor, a type of cancer drug, or an antibody-drug conjugate carrying a topoisomerase inhibitor. An antibody-drug conjugate links a drug to an antibody.
  • Past treatment with an antibody-drug conjugate aimed at Trop-2, a protein on some cancer cells.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (9)

CA

GA

KS

MO

TN

TX

VA