Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer
- 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.
- 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
Salt Lake City
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
- Primary ID IMMU-132-06 - TROPHY U-01
- Secondary IDs NCI-2018-03421
- Clinicaltrials.gov ID NCT03547973