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RECRUITING

NCT07421700

PHASE1/PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2026-03-11

Completion Date

2028-09-05

Last Updated

2026-07-08

Healthy Volunteers

Conditions

Urothelial Cancer Advanced/Metastatic Urothelial Cancer Urothelial Carcinoma

Interventions

BIOLOGICAL

PF-08634404

Concentrate for solution for Infusion.

BIOLOGICAL

Enfortumab Vedotin

Powder for concentrate for solution for infusion

Locations (93)

Highlands Oncology Group, PA

Fayetteville, Arkansas, United States

Highlands Oncology Group, PA

Rogers, Arkansas, United States

Highlands Oncology Group, PA

Springdale, Arkansas, United States

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

City of Hope Investigational Drug Services (IDS)

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

City of Hope Investigational Drug Service (IDS)

Irvine, California, United States

City of Hope-Long Beach (ELM)

Long Beach, California, United States

City of Hope UPLAND

Upland, California, United States

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Tennessee Oncology, PLLC- Ringgold

Ringgold, Georgia, United States

Memorial Hospital

Shiloh, Illinois, United States

Siteman Cancer Center - Shiloh

Shiloh, Illinois, United States

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri, United States

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States

Siteman Cancer Center - North County

Florissant, Missouri, United States

Siteman Cancer Center

St Louis, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Siteman Cancer Center - South County

St Louis, Missouri, United States

New York Oncology Hematology

Albany, New York, United States

New York Oncology Hematology

Clifton Park, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States

Oncology Associates of Oregon, P.C.

Springfield, Oregon, United States

Tennessee Oncology, PLLC - Chattanooga Downtown

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC - Chattanooga Med Park II

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC - Chattanooga Memorial

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC - Chattanooga East

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC- Cookeville

Cookeville, Tennessee, United States

Tennessee Oncology, PLLC - Dickson

Dickson, Tennessee, United States

Tennessee Oncology, PLLC - Franklin

Franklin, Tennessee, United States

Tennessee Oncology, PLLC - Proton Center

Franklin, Tennessee, United States

Tennessee Oncology, PLLC - Gallatin

Gallatin, Tennessee, United States

Tennessee Oncology, PLLC - Hendersonville

Hendersonville, Tennessee, United States

Tennessee Oncology, PLLC - Lebanon

Lebanon, Tennessee, United States

Tennessee Oncology, PLLC - Mount Juliet

Mount Juliet, Tennessee, United States

Tennessee Oncology, PLLC - Murfreesboro

Murfreesboro, Tennessee, United States

Sarah Cannon Research Institute