Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer

Inclusion Criteria

• Individuals able to understand and give written informed consent.
• Histologically or cytologically confirmed epithelial cancer of one of the following types:
• Gastric adenocarcinoma (GC)
• Esophageal cancer (EC)
• Hepatocellular carcinoma (HCC)
• Non-small-cell lung cancer (NSCLC)
• Small-cell lung cancer (SCLC)
• Epithelial ovarian cancer (EOC)
• Cervical Cancer
• Endometrial Cancer
• Triple-negative breast cancer (TNBC)
• Non-triple-negative breast cancer
• Papillary thyroid cancer (excludes follicular, medullary, Hurthle cell, and anaplastic thyroid cancer)
• Glioblastoma multiforme (GBM)
• Hormone-refractory prostate cancer (HRPC)
• Head and neck cancers- squamous cell (SCCHN)
• Renal cell cancer (clear cell) (RCC)
• Urothelial cancer
• Stage IV (metastatic) disease (except for individuals with GBM).
• Refractory to or relapsed after at least one prior standard therapeutic regimen
• Adequate performance status (ECOG 0 or 1)
• Expected survival ≥ 6 months.
• Measurable disease by CT or MRI.
• At least 2 weeks beyond treatment (chemotherapy, investigational drugs including small molecular inhibitors, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities to Grade 1 or less (except alopecia).
• At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
• Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
• Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
• Otherwise, all toxicity at study entry ≤ Grade 1.

Exclusion Criteria

• Women who are pregnant or lactating.
• Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
• Individuals with Gilbert's disease.
• Individuals with brain metastases can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (> 20 mg prednisone or equivalent) for at least 4 weeks.
• Presence of bulky disease (defined as any single mass > 7 cm in its greatest dimension). Individuals with a mass over 7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.
• Individuals with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
• Individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while individuals with other prior malignancies must have had at least a 3-year disease-free interval.
• Individuals known to be HIV positive, hepatitis B positive, or hepatitis C positive.
• Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
• Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
• Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of study treatment.
• Infection requiring intravenous antibiotic use within 1 week.
• History of an anaphylactic reaction to irinotecan or ≥ Grade 3 GI toxicity to prior irinotecan,
• Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.