Phase I Study Evaluating the Safety and Tolerability of Locally Administered Anti-CD40 Agonist Antibody (2141-V11) in Subjects With Bladder Cancer

Summary

The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder. The researchers will test different doses of 2141-V11 to see which dose is safest in people. The researchers will also do tests to see how the body absorbs, distributes, and gets rid of 2141-V11. This study is one of the first to test 2141-V11 in people, and the first to test 2141-V11 delivered through a catheter into the bladder.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  anti-CD40 antibody 2141-V11

  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.

• Drug
  anti-CD40 antibody 2141-V11

  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.

• Drug
  anti-CD40 antibody 2141-V11

  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 no sooner than 22 days of the last cycle of neoadjuvant therapy with enfortumab vedotin and pembrolizumab and prior to and within 4 weeks of planned radical cystectomy.

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