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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

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

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

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