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Clinical Trial 19988
Cancer Type: Genitourinary
Interventions:IMMU-132
Study Type: Treatment
Phase of Study: Phase II
Investigators:
- Rohit Jain
Call 813-745-6100 or 1-800-679-0775
Overview
Study Title
A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/ PD-L1 Based Immunotherapy
Summary
Objective
The objectives of this study is to evaluate the efficacy and safety of IMMU-132 in previously treated metastatic urothelial cancers.
Inclusion Criteria
Participants 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
