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

Completed · Phase 1/Phase 2

Conditions studied: Gastric Adenocarcinoma, Esophageal Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Ovarian Epithelial Cancer, Carcinoma Breast Stage IV, Hormone-refractory Prostate Cancer, Head and Neck Cancers- Squamous Cell, Renal Cell Cancer, Urinary Bladder Neoplasms, Cervical Cancer, Endometrial Cancer, Glioblastoma Multiforme, Triple Negative Breast Cancer, Pancreatic Cancer

In brief

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).

Key facts

Study ID

NCT01631552

Run by

Gilead Sciences

People needed

515

Starts

2012-12-17

Expected to finish

2020-08-13

Last updated by the study team

2021-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Helen F. Graham Cancer Center — Newark, Delaware, United States
• MD Anderson Cancer Center Orlando (UF Health Cancer Center) — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• IU Health Goshen Cancer Center — Goshen, Indiana, United States
• Massachusettes General Hospital — Boston, Massachusetts, United States
• Weill Cornell/New York Presbyterian Hospital — New York, New York, United States
• Columbia University Herbert Irving Cancer Center — New York, New York, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Texas Oncology Sammons Cancer Center — Dallas, Texas, United States
• Virginia Mason Cancer Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.