Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of sacituzumab govitecan-hziy administered in 21-day treatment cycles at a dose selected in Phase I. Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).
Checked against the public recordLast updated Aug 12, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Gilead Sciences
- Interventions being studied
- Drug: Sacituzumab Govitecan-hziy (SG)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Yale University School of MedicineNew Haven, Connecticut
- Helen F. Graham Cancer CenterNewark, Delaware
- MD Anderson Cancer Center Orlando (UF Health Cancer Center)Orlando, Florida
- Moffitt Cancer CenterTampa, Florida
- IU Health Goshen Cancer CenterGoshen, Indiana
- Massachusettes General HospitalBoston, Massachusetts
- Weill Cornell/New York Presbyterian HospitalNew York, New York
- Columbia University Herbert Irving Cancer CenterNew York, New York
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee
- Texas Oncology Sammons Cancer CenterDallas, Texas
- Virginia Mason Cancer CenterSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 12, 2021. Always confirm current availability with the study team.