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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

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
Rocky Mountain Cancer Centers, LLP
NOT_YET_RECRUITING
Aurora
Rocky Mountain Cancer Centers, LLP
NOT_YET_RECRUITING
Denver
Rocky Mountain Cancer Centers, LLP
NOT_YET_RECRUITING
Lone Tree
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology - Austin
RECRUITING
Austin
Texas Oncology - Central South
RECRUITING
Austin
Texas Oncology - Central/South Texas
RECRUITING
Austin
Texas Oncology - Central/South Texas
RECRUITING
Austin
Texas Oncology - Central/South Texas
RECRUITING
Austin
Texas Oncology - Central/South Texas
RECRUITING
Austin
Texas Oncology - Central/South Texas
RECRUITING
Harlingen
US Oncology Investigational Products Center (IPC)
NOT_YET_RECRUITING
Irving
Texas Oncology - Central/South Texas
RECRUITING
Mcallen
Texas Oncology - Central/South Texas
RECRUITING
Waco
Virginia
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Blacksburg
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Low Moor
Virginia Oncology Associates
NOT_YET_RECRUITING
Norfolk
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Roanoke
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Salem
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
RECRUITING
Wytheville
Other Locations
Australia
Icon Cancer Centre Wesley
RECRUITING
Auchenflower
Puerto Rico
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
RECRUITING
Rio Piedras
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-03-11
Estimated Completion Date: 2028-09-05
Participants
Target number of participants: 132
Treatments
Experimental: Cohort A
Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy.
Experimental: Cohort B
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin
Related Therapeutic Areas
Sponsors
Collaborators: Astellas Pharma Inc
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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