Status and phase
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Study type
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Identifiers
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:
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:
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:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
300 participants in 5 patient groups
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Central trial contact
Gilead Clinical Study Information Center
Data sourced from clinicaltrials.gov
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