Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer

StatusRecruiting
PhasePhase 1/2
SponsorPfizer
Started

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Record History

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  1. Minor Trial sites expanded: 173 → 184 locations
  2. Minor Trial sites expanded: 153 → 173 locations Show 4 more changesShow less
    • Primary completion date: Dec 6, 2027 to Dec 28, 2027
    • Study completion date: Sep 5, 2028 to Sep 25, 2028
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 2 of 6 entries
  3. Minor Trial sites expanded: 115 → 153 locationsv7
  4. Minor Trial sites expanded: 93 → 115 locationsv6
  5. Minor Trial sites expanded: 50 → 93 locationsv5
  6. Minor Trial sites expanded: 40 → 50 locationsv4
  7. Minor Trial sites expanded: 25 → 40 locationsv3
  8. Notable Recruitment opened
    • Trial sites expanded: 0 → 25 locations
    • Start date changed from estimate of Feb 27, 2026 to Mar 11, 2026
    • Study title expanded, about 1 word
    v2
  9. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
438 trials monitored
See 32 trials at risk
1,058 trials monitored
See 76 trials at risk
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.
Trial Details
NCT Number NCT07421700
Lead Sponsor Pfizer
Collaborators: Astellas Pharma Inc
Conditions
(from sponsor)
Urothelial Cancer, Advanced/Metastatic Urothelial Cancer, Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov