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

Non-small Cell Lung Cancer Clinical Trial

Official title:
A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer

Clinical Trial 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).

Clinical Trial Description

The outcome measures are planned to be assessed up to the data cutoff date. Following the data cutoff date, the participants will either stay on the study and will be followed for safety data collection or rolled into another Gilead-sponsored study. Therefore, only safety data will be collected after the data cutoff date. ;

Study Design

Related Conditions & MeSH terms

  • Breast Neoplasms
  • Carcinoma
  • Carcinoma Breast Stage IV
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Renal Cell
  • Cervical Cancer
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Esophageal Cancer
  • Gastric Adenocarcinoma
  • Glioblastoma
  • Glioblastoma Multiforme
  • Head and Neck Cancers- Squamous Cell
  • Hepatocellular Carcinoma
  • Hormone-refractory Prostate Cancer
  • Lung Neoplasms
  • Non-small Cell Lung Cancer
  • Ovarian Epithelial Cancer
  • Pancreatic Cancer
  • Renal Cell Cancer
  • Small Cell Lung Cancer
  • Small Cell Lung Carcinoma
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Urinary Bladder Neoplasms
Clinical Trial Details
NCT number NCT01631552
Study type Interventional
Source Gilead Sciences
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 17, 2012
Completion date August 13, 2020
View Details
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