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.