NCT07421700 Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
| NCT ID | NCT07421700 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Pfizer |
| Condition | Urothelial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2026-03-11 |
| Primary Completion | 2027-12-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 132 participants in total. It began in 2026-03-11 with a primary completion date of 2027-12-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years at the time of screening. * Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA/mUC). * Measurable disease per RECIST v1.1 criteria. * ECOG performance status of 0 or 1. * Adequate organ function, including hematologic, hepatic, and renal parameters. * Willingness to comply with study procedures and provide informed consent. * For participants of childbearing potential: agreement to use effective contraception during the study and for a defined period after the last dose. Exclusion Criteria: Participants will be excluded if they meet any of the following: * History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy * Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression * Active autoimmune diseases requiring systemic treatment within the past 2 years * Participation in another investigational study within 30 days or 5 half-lives of the investigational product. * Pregnant or breastfeeding individuals. * Inability or unwillingness to comply with study requirements. * Study staff or their immediate family members directly involved in the conduct of the study.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07421700 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07421700 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07421700 currently recruiting?
Yes, NCT07421700 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07421700 trial being conducted?
This trial is being conducted at Fayetteville, United States, Rogers, United States, Springdale, United States, Alhambra, United States and 11 additional locations.
Who is sponsoring the NCT07421700 clinical trial?
NCT07421700 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 132 participants.
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