Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment

Cohort A Eligible subjects will receive the anti-CD40 antibody 2141-V11 administered by intravesical instillation once weekly for 3 consecutive weeks (weeks 1, 2, and 3) for a total of 3 doses. As discussed further below, depending on disease status at week 13 and week 25 evaluations, subjects may be eligible for re-treatment (once weekly for 3 doses) at these time points.

Cohort B Eligible subjects will receive the anti-CD40 antibody 2141-V11 administered by intratumoral injection once every 3 weeks (weeks 1, 4, 7, and 10) for a total of 4 doses. As discussed further below, depending on disease status at week 14 and week 26 evaluations, subjects may be eligible for re-treatment (once every 3 weeks for a total of 4 doses) at these time points.

Cohort C Eligible subjects will receive the anti-CD40 antibody 2141-V11 administered by intratumoral injection as a single 10mg during standard of care cystoscopy and examination prior to and within 4 weeks of planned radical cystectomy.