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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Sacituzumab Govitecan-hziy (SG)
  Administered intravenously

Первичные конечные точки

• Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) [Срок оценки: First dose up to 28 days]
• Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs) [Срок оценки: First dose up to 30 days post last dose (Up to 3 years)]
• Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities [Срок оценки: First 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 Discontinuations [Срок оценки: First dose up to 30 days post last dose (Up to 3 years).]
• Phases 1 and 2: Objective Response Rate (ORR) [Срок оценки: Up to 9 months]
• Phase 2: Progression-Free Survival (PFS) [Срок оценки: Up to 9 months]

Вторичные конечные точки (4)

• Phases 1 and 2: Serum Concentrations of SG [Срок оценки: Up to End of Treatment (3 years)]
• Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG [Срок оценки: First dose up to 30 days post last dose (Up to 3 years).]
• Phase 2: Duration of Response (DOR) [Срок оценки: First dose up to 30 days post last dose (Up to 3 years).]
• Phase 2: Disease Control Rate (DCR) [Срок оценки: Up to 9 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• Los Angeles Cancer Network (LACN) - Good Sam — Los Angeles
• Winship Cancer Institute - Emory University — Atlanta
• The University of Kansas Hospital — Westwood
• Siteman Cancer Center — St Louis
• West Cancer Centre — Germantown
• SCRI Oncology Partners — Nashville
• Tennessee Oncology, PLLC — Nashville
• Texas Oncology - DFW — Dallas
• … и ещё 1 центр

South Korea · 4 центра

• Seoul National University Hospital — Seoul
• Severance Hospital, Yonsei University Health System — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul

Австралия · 3 центра

• St. Vincent's Hospital - Kinghorn Cancer Center — Darlinghurst
• Sunshine Coast University Private Hospital — Birtinya
• John Flynn Private Hospital — Tugun

Идентификаторы

NCT: NCT06926920 · GS-US-576-7321 · 2024-519124-25 · 2024-519124-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗