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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 is a Phase 1 study that has not yet begun recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 27 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07667335
The ClinicalTrials.gov registry entry for NCT07667335 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07667335 reports 0 study locations.
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.
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