Study of Sacituzumab Govitecan in Patients With Solid Tumor
NCT ID: NCT05119907
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
53 participants
INTERVENTIONAL
2021-10-12
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
NCT05101096
A Phase I Clinical Study to Evaluate the Safety, the Tolerability, the Pharmacokinetic Characteristics and the Efficacy of ScTIL Injection (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Advanced Malignant Solid Tumors
NCT05499715
Study of GV20-0251 in Participants With Solid Tumor Malignancies
NCT07070518
Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
NCT06903377
Study of LM-302 in Patients With Advance Solid Tumors
NCT05161390
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A: Esophageal Squamous Cell Carcinoma (ESCC)
Participants will receive Sacituzumab Govitecan-hziy (SG) 8 or 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.
Sacituzumab Govitecan-hziy
Administered intravenously
Cohort B: Gastric or Gastroesophageal Junction Adenocarcinoma (G/GEJC)
Participants will receive SG 8 or 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.
Sacituzumab Govitecan-hziy
Administered intravenously
Cohort C: Cervical Cancer (CC)
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.
Sacituzumab Govitecan-hziy
Administered intravenously
Cohort D: Biliary Tract Cancer (BTC)
Participants will receive SG 8 or 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.
Sacituzumab Govitecan-hziy
Administered intravenously
Cohort E: Lung Adenocarcinoma (LAC)
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.
Sacituzumab Govitecan-hziy
Administered intravenously
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sacituzumab Govitecan-hziy
Administered intravenously
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically-documented, incurable locally advanced or metastatic solid tumor of one of the following types:
* Cohort A: oesophageal squamous-cell carcinoma that was refractory or intolerant to fluoropyrimidine-based, platinum-based, and taxane-based chemotherapy.
* Cohort B: gastric adenocarcinoma that was refractory or intolerant to fluoropyrimidine-based, platinum-based, and taxane-based chemotherapy.
* Cohort C: cervical cancer that was refractory or intolerant to platinum-based and taxane-based chemotherapy.
* Cohort D: biliary tract cancer, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and gallbladder cancer (GBC), with exception of ampullary carcinoma, progressed during or after first line platinum-based or fluoropyrimidine-based chemotherapy.
* Cohort E: lung adenocarcinoma with activating genomic alterations (EGFR/ ALK/ ROS1/ BRAF/ MET/ RET) that was refractory or intolerant to targeted tyrosine kinase inhibitors (TKIs) and had not received platinum-based chemotherapy for unresectable local advanced or metastatic disease, and no suitable or willing to receive platinum-based chemotherapy.
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.
* Availability of archival tumor tissue or newly acquired biopsy (unstaining tumor slides, recommended from metastasis sites).
* Adequate bone marrow, hepatic and renal function.
* Recovered from all prior treatment-related toxicities to Grade 1 or less by NCI-CTCAE v 5.0 (except alopecia or peripheral neuropathy that may be Grade 2 or less).
* Individuals must have completed all prior cancer treatments at least 2 weeks prior to the first dose including chemotherapy , radiotherapy and major surgery. Prior antibody treatment for cancer must have been completed at least 3 weeks prior to the first dose.
* Individuals must have at least a 3-month life expectancy.
Exclusion Criteria
* Previous treatment with Trop-2 targeted therapy.
* Individuals with a history of or current central nervous system (CNS) metastases.
* Known additional malignancy within 3 years prior to enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers.
* Individuals known to be human immunodeficiency virus positive.
* Individuals with active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Hepatitis B core antibody (HBcAb) testing is required and if positive, then HBV DNA testing will be performed and if positive the individual will be excluded.
* Known history of unstable angina, myocardial infarction (MI), or chronic heart failure present within 6 months of first dose or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy or left ventricular ejection fraction \< 50%.
* Known history of clinically significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness present within 6 months of the first dose.
* Infection requiring systematic antibiotic use within 1 week of the first dose.
* Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and individuals with a history of bowel obstruction or gastrointestinal (GI) perforation.
* High dose systemic corticosteroids within 2 weeks prior to the first dose (however, low dose corticosteroids ≤ 10 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).
* Individuals who have received a live vaccine within 30 days of first dose.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, , China
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Fujian Cancer Hospital
Fuzhou, , China
The Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Provincial Hospital
Hefei, , China
Jiangsu Province Hospital
Nanjing, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Gilead Clinical Trials Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTR20210912
Identifier Type: REGISTRY
Identifier Source: secondary_id
EVER-132-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.