Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07421700

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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