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

Recruiting now · Phase 1/Phase 2

Conditions studied: Urothelial Cancer, Advanced/Metastatic Urothelial Cancer, Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT07421700

Run by

Pfizer

People needed

132

Starts

2026-03-11

Expected to finish

2028-09-05

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Siteman Cancer Center - South County — St Louis, Missouri, United States (enrolling)
• New York Oncology Hematology — Albany, New York, United States (enrolling)
• Highlands Oncology Group, PA — Rogers, Arkansas, United States (enrolling)
• Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• City of Hope at Irvine Lennar — Irvine, California, United States (enrolling)
• Highlands Oncology Group, PA — Fayetteville, Arkansas, United States (enrolling)
• City of Hope-Long Beach (ELM) — Long Beach, California, United States (enrolling)
• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States (enrolling)
• Siteman Cancer Center - North County — Florissant, Missouri, United States (enrolling)
• Barnes-Jewish Hospital — St Louis, Missouri, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States (enrolling)
• Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States (enrolling)
• City of Hope Investigational Drug Service (IDS) — Irvine, California, United States (enrolling)
• Highlands Oncology Group, PA — Springdale, Arkansas, United States (enrolling)
• Tennessee Oncology, PLLC- Ringgold — Ringgold, Georgia, United States (enrolling)
• Memorial Hospital — Shiloh, Illinois, United States (enrolling)
• Siteman Cancer Center - Shiloh — Shiloh, Illinois, United States (enrolling)
• City of Hope UPLAND — Upland, California, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Aurora, Colorado, United States (enrolling)
• City of Hope Investigational Drug Services (IDS) — Duarte, California, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States (enrolling)
• Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• Siteman Cancer Center - St. Peters — City of Saint Peters, Missouri, United States (enrolling)
• Siteman Cancer Center - West County — Creve Coeur, Missouri, United States (enrolling)
• New York Oncology Hematology — Clifton Park, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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