NCT01631552 (Clinical Trial/ SACITUZUMAB GOVITECAN/ IMMU-132 / HRS7-SN38)

Study Title
Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers (NCT01631552)

Trial Description

The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles for up to 8 cycles, in previously treated patients with advanced epithelial cancer.The secondary objectives are to obtain initial data concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers.

The antibody, RS7, is attached to SN38, which is the active metabolite of irinotecan. This is planned as a multi-center study. In Phase II, up to 130 patients (assessable) in triple-negative breast cancer, up to 100 patients (assessable) in non-small cell and small-cell lung cancer and up to 50 patients (assessable) per other cancer types included in the protocol will be studied at the 10 mg/kg dose.

This trial is sponsored by Immunomedics, Inc.

Study Data

• Condition:
  • Colorectal Cancer
  • 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
  • Pancreatic Ductal Adenocarcinoma
  • Head and Neck Cancers- Squamous Cell
  • Renal Cell Cancer
  • Urinary Bladder Neoplasms
  • Cervical Cancer
  • Endometrial Cancer
  • Follicular Thyroid Cancer
  • Glioblastoma Multiforme
• Interventions:
  • Drugs used in this trial
    • IMMU-132
• Phase: I & II
• Estimated Enrollment: 250
• Start: February 2013
• Estimated Completion: June 2016
• Last verified: December 2015
• Last updated: December 2015

Study Schematic

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Last Editorial review: November 9, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.