Actively Recruiting
Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
Led by Pfizer · Updated on 2026-04-20
132
Participants Needed
40
Research Sites
129 weeks
Total Duration
On this page
Sponsors
P
Pfizer
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of screening
- Histologically confirmed locally advanced or metastatic urothelial carcinoma
- Measurable disease according to RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Adequate organ function including blood, liver, and kidney tests
- Willingness to follow study procedures and provide informed consent
- For those who can have children: agreement to use effective contraception during the study and for a specified time after the last dose
You will not qualify if you...
- History of another cancer within 3 years before starting the study or any remaining disease from a previous cancer
- Known active central nervous system lesions such as brain or spinal cord metastases or compression
- Active autoimmune diseases requiring systemic treatment within the last 2 years
- Participation in another investigational study within 30 days or within 5 half-lives of the prior investigational drug
- Pregnant or breastfeeding individuals
- Inability or unwillingness to follow study requirements
- Study staff or their immediate family members involved in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States, 72703
Not Yet Recruiting
2
Highlands Oncology Group, PA
Rogers, Arkansas, United States, 72758
Not Yet Recruiting
3
Highlands Oncology Group, PA
Springdale, Arkansas, United States, 72762
Not Yet Recruiting
4
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States, 80012
Actively Recruiting
5
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80218
Actively Recruiting
6
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States, 80124
Actively Recruiting
7
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
Not Yet Recruiting
8
New York Oncology Hematology
Albany, New York, United States, 12206
Not Yet Recruiting
9
New York Oncology Hematology
Clifton Park, New York, United States, 12065
Not Yet Recruiting
10
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78705
Actively Recruiting
13
Texas Oncology - Austin
Austin, Texas, United States, 78731
Actively Recruiting
14
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78731
Actively Recruiting
15
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78745
Actively Recruiting
16
Texas Oncology - Central South
Austin, Texas, United States, 78758
Actively Recruiting
17
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78758
Actively Recruiting
18
Texas Oncology - Gulf Coast
Beaumont, Texas, United States, 77702
Actively Recruiting
19
Texas Oncology - Central/South Texas
Harlingen, Texas, United States, 78550
Actively Recruiting
20
Texas Oncology - Gulf Coast
Houston, Texas, United States, 77024
Actively Recruiting
21
Texas Oncology - Gulf Coast
Houston, Texas, United States, 77054
Actively Recruiting
22
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States, 75063
Not Yet Recruiting
23
Texas Oncology - Central/South Texas
McAllen, Texas, United States, 78503
Actively Recruiting
24
Texas Oncology - Gulf Coast
Pearland, Texas, United States, 77584
Actively Recruiting
25
Texas Oncology - Gulf Coast
Sugar Land, Texas, United States, 77479
Actively Recruiting
26
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States, 77380
Actively Recruiting
27
Texas Oncology - Central/South Texas
Waco, Texas, United States, 76712
Actively Recruiting
28
Texas Oncology - Gulf Coast
Webster, Texas, United States, 77598
Actively Recruiting
29
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Blacksburg, Virginia, United States, 24060
Actively Recruiting
30
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
31
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Low Moor, Virginia, United States, 24457
Actively Recruiting
32
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Not Yet Recruiting
33
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Actively Recruiting
34
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
Actively Recruiting
35
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Wytheville, Virginia, United States, 24382
Actively Recruiting
36
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
37
Keio university hospital
Shinjuku-ku, Tokyo, Japan, 1608582
Not Yet Recruiting
38
Yamagata University Hospital
Yamagata, Japan, 990-9585
Not Yet Recruiting
39
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
40
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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