Joint Clinical Trials Office

You are here

A Phase 2 Open Label Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1 / PD-L1 Based Immunotherapy

Clinical Trial Details

The primary objective of this trial is to evaluate the effectiveness and safety of IMMU-13 in men and women with bladder cancer

IMMU-132 is an antibody drug conjugate which has demonstrated promising single-agent activity in a small phase 2 study with a good safety profile. There is a need for potent chemo-therapeutic agents not interfering with immunotherapy which is likely the case of IMMU-132. Preliminary data suggest significant effectiveness improvement over available therapies after 1st line failure. 

A cycle is 21 days, and screening evaluations will occur 28 days prior to first dose. Patients will receive IMMU-132, 10 mg/kg intravenously (IV) on days 1 and 8 of each cycle. Safety follow-up will be 30 days after the last dose and then will be followed every 12 weeks for survival follow-up. 

There are two cohorts: 

  • Cohort 1: Study of IMMU-132 third-line therapy of bladder cancer, after platinum-based and PD-1 / PD-L1 based therapies failure.
  • Cohort 2: Study of IMMU-132 second-line therapy of bladder cancer, ineligible for platinum-based therapy. 

Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. 

Key Eligibility: 
  • Women and men 18 and older who have been diagnosed with bladder cancer 
  • Prior therapies:
    - Cohort 1: have had progression or recurrence of bladder cancer following receipt of platinum- containing regimen (cisplatin or carboplatin) and anti-PD-1/anti-PD-L1 therapy. 
    - Cohort 2: have had progression or recurrence of bladder cancer after a first-line therapy for metastatic disease. 
  • Detailed eligibility reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Lauren Emmerich, RN
(212) 746-2651
guonc@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1804019145

ClinicalTrials.gov:

NCT03547973

Status

Open to Enrollment

Age Group

Adult

Sponsor