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NCT07667335 · ClinicalTrials.gov registry record · Phase 1
Enfortumab Vedotin, Pembrolizumab and Quemliclustat for the Treatment of Unresectable Locally Advanced and Metastatic Urothelial Cancer
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT07667335: Clinical Trial Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT07667335 is a Phase 1 study that has not yet begun recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07667335, a Phase 1 study, has not yet begun recruiting, sponsored by Fred Hutchinson Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This phase Ib/II trial tests the safety, side effects, and best dose of quemliclustat in combination with enfortumab vedotin and pembrolizumab, and to see how well the combination works for the treatment of bladder, renal pelvis, or ureter urothelial cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving quemliclustat in combination with enfortumab vedotin and pembrolizumab and may be safe, tolerable and/or effective in treating patients with unresectable locally advanced and metastatic urothelial cancer.
Primary Outcome
As measured by Common Terminology Criteria for Adverse Events version (v) 6.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Enfortumab Vedotin
- PROCEDURE Magnetic Resonance Imaging
- DRUG Quemliclustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2026-12-01 |
| Est. Completion | 2029-07-16 |
| Phase | Phase 1 |
What is known before NCT07667335 opens enrollment
NCT07667335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07667335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07667335 about?
NCT07667335 is a clinical study titled "Enfortumab Vedotin, Pembrolizumab and Quemliclustat for the Treatment of Unresectable Locally Advanced and Metastatic Urothelial Cancer". This phase Ib/II trial tests the safety, side effects, and best dose of quemliclustat in combination with enfortumab vedotin and pembrolizumab, and to see how well the combination works for the treatment of bladder, renal pelvis, or ureter urothelial cancer that cannot be removed by surgery (unresec...
What is the current status of trial NCT07667335?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2026-12-01. Estimated completion is 2029-07-16.
What interventions are being tested in trial NCT07667335?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Enfortumab Vedotin (DRUG), Magnetic Resonance Imaging (PROCEDURE), Quemliclustat (DRUG).
Who is sponsoring clinical trial NCT07667335?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07667335's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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