Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
Background: * Human trophoblast cell-surface marker (TROP2) is a surface glycoprotein originally identified in human placental tissue and highly expressed in gynecologic malignancies. TROP2 overexpression in ovarian, endometrial, and cervical cancers is linked to tumorigenicity and poor overall survival. * Sacituzumab govitecan (SG) is an antibody-drug conjugate (ADC) of an Immunoglobulin G (IgG(kappa)1 monoclonal antibody targeting TROP2 with a chemotherapeutic payload of SN-38. SN-38 is an active metabolite of irinotecan and acts as a topoisomerase I inhibitor. * Preclinical data suggest that SG induces deoxyribonucleic acid (DNA) damage, replication stress, and tumor shrinkage in drug-resistant ovarian, endometrial, and cervical cancer in vitro and in vivo preclinical models. * Further clinical and translational studies are needed to better understand SGs clinical activity and biology in relapsed gynecologic cancer patients. Objective: -To determine the objective response rate (ORR) of sacituzumab govitecan (SG) in participants with recurrent gynecological malignancies, calculated for each individual tumor histology by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Eligibility: * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<= 1 * Histologically documented, recurrent platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer (referred to as ovarian cancer); recurrent endometrioid or serous endometrial cancer; or recurrent epithelial cervical cancer * At least two prior systemic therapeutic regimens * Measurable disease by RECIST v1.1 criteria with lesions that can be safely biopsied * No prior TROP2-targeting antibody drug conjugates (ADC) Design: * This is an open label, non-randomized Phase II pilot study with one Arm. * SG will be administered intravenously (IV) at 10 mg/kg on Days 1 and 8 each 21-day cycle. * Tumor assessments will be time-based: every 9 weeks (+/- 1 week) for the first year and every 12 weeks (+/- 1 week) thereafter until disease progression. Pre-treatment biopsies and serial blood samples will be collected for the correlative studies. * Treatment will be given for a maximum of 5 years or until disease progression or unacceptable toxicities. * Up to 66 evaluable participants will be enrolled.
Age
18–120
Sex
FEMALE
Healthy volunteers
Not accepted
