A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Purpose
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).
Condition
- Triple Negative Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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 Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1 |
Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met. |
|
|
Experimental Phase 2: Expansion |
Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met. |
|
Recruiting Locations
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California 90017
Los Angeles, California 90017
More Details
- NCT ID
- NCT06926920
- Status
- Recruiting
- Sponsor
- Gilead Sciences
Study Contact
Gilead Clinical Study Information Center1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com
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.