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

• Status: Completed
• Trial end date: 2020-08-13
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences; Immunomedics, Inc.
• Treatments: Irinotecan

Criteria

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.