RecruitingPhase 1NCT05126472

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

55 participants

Start Date

Nov 8, 2021

Study Type

INTERVENTIONAL

Conditions

Non Muscle Invasive 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new treatment called 2141-V11 — an experimental drug delivered directly into the bladder — for people with high-grade non-muscle-invasive bladder cancer (NMIBC) that has not responded to BCG therapy (the standard immunotherapy for this condition). NMIBC that fails BCG is difficult to treat without surgery. This drug aims to provide a bladder-preserving option. **You may be eligible if...** - You have high-grade non-muscle-invasive bladder cancer (urothelial type — stages Ta high-grade, T1, or carcinoma in situ) that has not responded to adequate BCG treatment - Your cancer type and stage have been confirmed by the study's pathology team - BCG therapy is considered to have been adequate if you completed at least 5 of 6 induction doses plus 2 of 3 maintenance doses, or 2 full induction courses **You may NOT be eligible if...** - Your cancer has invaded the bladder muscle wall or spread to lymph nodes/other organs - Your tumor is predominantly non-urothelial (e.g., squamous or adenocarcinoma) - You have had BCG-related serious complications (BCG sepsis) - You have active autoimmune conditions or are on immunosuppressive therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGanti-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.

DRUGanti-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.

DRUGanti-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.