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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Gilead Sciences
Study ID
NCT06926920
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Govitecan-hziy (SG) — DRUG
    Administered intravenously

Study Details

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).

Key Dates

Start date
Apr 30, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: First dose up to 28 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Los Angeles Cancer Network (LACN) - Good SamLos AngelesCalifornia90017-
Winship Cancer Institute - Emory UniversityAtlantaGeorgia30322-
The University of Kansas HospitalWestwoodKansas66205-
Siteman Cancer CenterSt LouisMissouri63110-
West Cancer CentreGermantownTennessee38138-
SCRI Oncology PartnersNashvilleTennessee37203-
Tennessee Oncology, PLLCNashvilleTennessee37203-
Texas Oncology - DFWDallasTexas75246-
Virginia Oncology AssociatesNorfolkVirginia23502-

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Los Angeles Cancer Network (LACN) - Good Sam· Los Angeles, CAWinship Cancer Institute - Emory University· Atlanta, GAThe University of Kansas Hospital· Westwood, KSSiteman Cancer Center· St Louis, MOWest Cancer Centre· Germantown, TNSCRI Oncology Partners· Nashville, TN

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