A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

Gilead Sciences121 个研究点分布在 7 个国家目标入组 227 人开始时间: 2019年10月15日最近更新: 2026年4月28日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方: Gilead Sciences
入组人数: 227
试验地点: 121
主要终点: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) solid tumors.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
•NSCLC [adenocarcinoma or squamous cell carcinoma (SCC)] that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
•HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
•Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
•Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
•Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
•Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
•Adequate hepatic and renal function [Creatinine Clearance (CrCl) ≥30mL/min]
•Individual must have at least a 3-month life expectancy
•Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

排除标准

•Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1
•Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent
•Have previously received topoisomerase I inhibitors
•Have an active second malignancy
•Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking ≤20 mg/day of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability
•Additional cohort specific exclusion criteria
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

研究组 & 干预措施

Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Experimental

Participants with ES-SCLC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.