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Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer

Trial Status: Active

This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 / PD-L1 based immunotherapy. At least 140 patients are anticipated to be enrolled across approximately 70 sites from North America, Europe and Asia.

Inclusion Criteria

  • Patients with histologically confirmed urothelial cancer.
  • ECOG Performance status score of 0 or 1.
  • Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):
  • Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
  • Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy.
  • Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an anti-PD-1 /PD-L1 therapy.
  • Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Subject may not have received any platinum for treatment of recurrent, metastatic or advanced disease.
  • Adequate renal and hepatic function.
  • Adequate hematologic parameters without transfusional support.
  • Creatinine clearance ≥30mL/min as calculated by the Cockroft-Gault formula.
  • Subjects must have a 3-month life expectancy.
  • Have measurable disease by CT or MRI as per RECIST 1.1 criteria.

Exclusion Criteria

  • Women who are pregnant or lactating.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Requires concomitant medication interfering with ABCA1 transporter or UGT1A1
  • Has an active second malignancy.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has known active Hepatitis B or Hepatitis C
  • Has other concurrent medical or psychiatric conditions

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

Connecticut

New Haven
Yale University
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: APPROVED
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Texas

San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: ACTIVE
Contact: Sonia Lisa Creighton
Phone: 210-450-1366

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen and/or anti-PD-1 / PD-L1 based immunotherapy. The primary objective is Objective Response Rate (ORR) based on central review. The secondary objectives are Duration of Response (DOR) and Progression Free Survival (PFS) both based on central review and Overall Survival (OS). Subjects will receive IMMU-132 10 mg/kg administered intravenously on Days 1 and 8 of a 21-day cycle to be continued in the absence of unacceptable toxicity or progression of disease requiring termination of further treatment. After discontinuation of treatment, patients will have a 30-day safety follow-up after last dose and then will be followed every 12 weeks for survival for a minimum of 2 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Immunomedics Inc

  • Primary ID IMMU-132-06 - TROPHY U-01
  • Secondary IDs NCI-2018-03421
  • Clinicaltrials.gov ID NCT03547973