Clinical trial NCT06926920: A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Triple Negative Breast Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

Detailed description: 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: 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.

Primary outcomes:
measure: Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
timeFrame: First dose up to 28 days
measure: Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs)
timeFrame: First dose up to 30 days post last dose (Up to 3 years)
measure: Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities
timeFrame: First dose up to 30 days post last dose (Up to 3 years).
measure: Phases 1 and 2: Percentages of Participants Experiencing AEs Leading to Dose Reductions, Dose Interruptions, and Treatment Discontinuations
timeFrame: First dose up to 30 days post last dose (Up to 3 years).
measure: Phases 1 and 2: Objective Response Rate (ORR)
timeFrame: Up to 9 months
measure: Phase 2: Progression-Free Survival (PFS)
timeFrame: Up to 9 months
Secondary outcomes:
measure: Phases 1 and 2: Serum Concentrations of SG
timeFrame: Up to End of Treatment (3 years)
measure: Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG
timeFrame: First dose up to 30 days post last dose (Up to 3 years).
measure: Phase 2: Duration of Response (DOR)
timeFrame: First dose up to 30 days post last dose (Up to 3 years).
measure: Phase 2: Disease Control Rate (DCR)
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Cancer Network (LACN) - Good Sam
state: California
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: