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NCT05126472 · ClinicalTrials.gov registry record · Phase 1
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
A Phase 1 study of Non-muscle Invasive Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 7
- Study locations
NCT05126472: Recruiting Phase 1 study of Non-muscle Invasive Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05126472 is a Phase 1 study of Non-muscle Invasive Bladder Cancer that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 55 participants, below the 225-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (76% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05126472, a Phase 1 study of Non-muscle Invasive Bladder Cancer, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
The MTD will be defined as the dose level at which the estimated DLT rate from the MCRM model is closest to the target acceptable rate of 20%. If an MTD is not found after the full dose escalation study has been completed, the next dose recommended by the MCRM algorithm will be considered the RP2D. A DLT will be defined as the occurrence of any clinically significant grade 3 or 4 AE (per CTCAE version 5.0) within the DLT evaluation period that is considered by the Principal Investigator or desig
Conditions Studied
Interventions
- DRUG anti-CD40 antibody 2141-V11
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-11-08 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What NCT05126472 shows while recruiting
NCT05126472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 225-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which anti-CD40 antibody 2141-V11 is the first listed.
NCT05126472 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05126472 about?
NCT05126472 is a clinical study titled "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 pe...
What is the current status of trial NCT05126472?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2021-11-08. Estimated completion is 2026-11.
What conditions does trial NCT05126472 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.
What interventions are being tested in trial NCT05126472?
The interventions under investigation include: anti-CD40 antibody 2141-V11 (DRUG).
Who is sponsoring clinical trial NCT05126472?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05126472 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05126472's enrollment target sits among peer trials
55 20th of 30 higher than 10 of 30 other Non-muscle Invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-muscle Invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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