study of sacituzumab govitecan in patients with solid tumor

Conditions: Solid Tumor

Summary: the goal of this study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with solid tumor.

only cohort c: cervical cancer (cc) is enrolling at this time.

Eligibility 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: * 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.