Study of Sacituzumab Govitecan in Patients With Solid Tumor
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The goal of this study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with solid tumor.
Full description
Only Cohort C: Cervical Cancer (CC) is enrolling at this time.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
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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.
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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.
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Availability of archival tumor tissue or newly acquired biopsy (unstaining tumor slides, recommended from metastasis sites).
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Adequate bone marrow, hepatic and renal function.
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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).
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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.
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
300 participants in 5 patient groups
Trial contacts and locations
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Central trial contact
Gilead Clinical Study Information Center
Data sourced from clinicaltrials.gov
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