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

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.

Trial Details

NCT ID
NCT05126472
Phase
PHASE1
Sponsor
Memorial Sloan Kettering Cancer Center
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • anti-CD40 antibody 2141-V11
Locations (sample)
  • Basking Ridge, New Jersey, United States|40.70621,-74.54932
  • Middletown, New Jersey, United States|40.39428,-74.11709
  • Montvale, New Jersey, United States|41.04676,-74.02292
  • Commack, New York, United States|40.84288,-73.29289
  • Harrison, New York, United States|40.96899,-73.71263

Key Eligibility Criteria

  • Cohorts A and B
  • High-grade (HG) NMIBC (HG Ta, CIS, and/or T1) of urothelial histology that is unresponsive to adequate BCG therapy.
  • Stage, grade, and histology must be confirmed by the MSK Department of Pathology
  • Subjects with tumors of mixed urothelial/non-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subj…

For full eligibility, visit ClinicalTrials.gov.

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