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

Conditions

• Non-muscle Invasive Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• anti-CD40 antibody 2141-V11 — DRUG
  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.
• anti-CD40 antibody 2141-V11 — DRUG
  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.
• anti-CD40 antibody 2141-V11 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Nov 8, 2021

Status verified

May 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

55 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: (Cohort A) anti-CD40 antibody 2141-V11
  Intravesically or intratumorally) of an anti-CD40 agonist antibody (2141-V11) for the treatment of subjects with BCG-unresponsive NMIBC who are considered ineligible for or have elected not to undergo radical cystectomy.
• Experimental: (Cohort B) 2141-V11, a fixed dose of 10mg
  For patients who are ineligible for radical cystectomy or have elected not to undergo the procedure.
• Experimental: (Cohort C) expansion cohort 10 mg of 2141-V11
  For patients in Cohort C, 10 mg of 2141-V11 will be administered as an intratumoral injection during standard of care cystoscopy no sooner than day 22 of the last cycle of neoadjuvant enfortumab vedotin + pembrolizumab and prior to and within four weeks of planned radical cystectomy.

Primary Outcome Measure

MTD/RP2D (Cohort A) [ Time Frame: 2 years ]

Central Contacts

• Bernard Bochner, MD
  646-422-4387
  [email protected]
• Eugene Pietzak, MD
  646-422-4781

Locations (7)

Find similar trials in Basking Ridge, NJ

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