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NCT07421700 · ClinicalTrials.gov registry record · Phase 1
Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
A Phase 1 study, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
NCT07421700: Recruiting Phase 1 study, sponsored by Pfizer.
NCT07421700 is a Phase 1 study that is actively recruiting participants, run by Pfizer. The registered enrollment target is 132 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07421700, a Phase 1 study, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
Study Summary
This study is being done to learn more about a new medicine called PF-08634404. It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA/mUC), meaning the cancer has spread to nearby tissues or other parts of the body. The purpose of the study is to see if PF-08634404 is safe, how well it works, how it moves through the body, and how it affects the cancer. The study will also look at how the medicine may change certain markers in the body that are linked to cancer. To join the study, participants must: * Be adults (18 years or older) and * Have locally advanced or metastatic urothelial cancer, The study has two groups: * Cohort A: People who have already received treatment for their cancer will get the study medicine ( PF-08634404) alone. * Cohort B: People who have not had treatment before will get the study medicine along with another cancer medicine called enfortumab vedotin. Everyone in the study will get the study medicine through a vein (IV infusion) with or without enfortumab vedotin. Treatment will continue as long as it helps and side effects are manageable. Before starting, participants will go through a screening period to check if they are eligible. During the study, they will have regular visits for treatment, health checks, and tests to see how the cancer is responding. Scans will be done regularly to monitor the cancer. If the cancer gets worse but the treatment is still helping and side effects are manageable, participants may be allowed to continue treatment with their doctor's and the sponsor's agreement.
Primary Outcome
ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator.
Interventions
- BIOLOGICAL PF-08634404
- BIOLOGICAL Enfortumab Vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2026-03-11 |
| Est. Completion | 2028-09-05 |
| Phase | Phase 1 |
What NCT07421700 shows while recruiting
NCT07421700 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 2 interventions - of which PF-08634404 is the first listed.
NCT07421700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07421700 about?
NCT07421700 is a clinical study titled "Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer". This study is being done to learn more about a new medicine called PF-08634404. It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA/mUC), meaning the cancer has spread to nearby tissues or other parts of the body. The purpose of the study is to...
What is the current status of trial NCT07421700?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2026-03-11. Estimated completion is 2028-09-05.
What interventions are being tested in trial NCT07421700?
The interventions under investigation include: PF-08634404 (BIOLOGICAL), Enfortumab Vedotin (BIOLOGICAL).
Who is sponsoring clinical trial NCT07421700?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07421700's enrollment target sits among peer trials
132 432nd of 2000 higher than 1,562 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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