New drug shows promise against tough cancers
NCT ID NCT05119907
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called sacituzumab govitecan in 53 adults with advanced solid tumors that have not responded to standard treatments. The main goal is to see if the drug can shrink tumors. Researchers will also track how long any response lasts and how well the drug controls the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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53 people
The number who actually took part.
- Started
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Oct 2021
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * 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. Key Exclusion Criteria: * Previous treatment with topoisomerase I inhibitors as a free form or as other formulations. * 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anhui Provincial Hospital
Hefei, 230001, China
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Beijing Cancer Hospital
Beijing, 100142, China
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Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, 100006, China
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Chinese Academy of Medical Sciences Cancer Hospital
Beijing, 100021, China
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Fujian Cancer Hospital
Fuzhou, 350014, China
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Harbin Medical University Cancer Hospital
Harbin, 150076, China
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Henan Cancer Hospital
Zhengzhou, 450000, China
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Jiangsu Province Hospital
Nanjing, 210029, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, 310003, China
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The First Hospital of Jilin University
Changchun, 130021, China
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The Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, 510655, China
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 43006, China
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Zhejiang Cancer Hospital
Hangzhou, 310022, China
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