Urothelial CancerPhase 1/2NCT07421700

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

A Phase 1/2 study testing PF-08634404 and Enfortumab Vedotin in people with Urothelial Cancer and Advanced/Metastatic Urothelial Cancer, run by Pfizer at 184 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urothelial Cancer, Advanced/Metastatic Urothelial Cancer, Urothelial Carcinoma
What is being tested?: PF-08634404 and Enfortumab Vedotin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 184 sitesin 6 countries
Study dates: 11 Mar 2026to 25 Sep 2028
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

184 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Country

City, postcode or hospital

Sites recruiting now only

184 sites in 6 countries

United States164 sites, 164 recruiting

New York Oncology Hematology
Albany, New York, 12206
Recruiting
UCLA Hematology/Oncology - Alhambra
Alhambra, California, 91801
Recruiting
UCLA Hematology/Oncology - Atascadero
Atascadero, California, 93422
Recruiting
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012
Recruiting
Texas Oncology - Central/South Texas
Austin, Texas, 78705
Recruiting
Texas Oncology - Central/South Texas
Austin, Texas, 78731
Recruiting
Texas Oncology - Central/South Texas
Austin, Texas, 78745
Recruiting
Oncology Research Pharmacy and lnvestigational Drug Service
Baltimore, Maryland, 21231
Recruiting
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Recruiting
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
Recruiting
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Recruiting
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
Not yet recruiting
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702
Recruiting
UCLA Hematology/Oncology - Beverly Hills
Beverly Hills, California, 90212
Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Recruiting
UCLA Hematology/Oncology - Burbank
Burbank, California, 91505
Recruiting
Duke Cancer Center Cary
Cary, North Carolina, 27518
Recruiting
Tennessee Oncology, PLLC - Chattanooga Downtown
Chattanooga, Tennessee, 37403
Recruiting
Tennessee Oncology, PLLC - Chattanooga Med Park II
Chattanooga, Tennessee, 37404
Recruiting
Tennessee Oncology, PLLC - Chattanooga Memorial
Chattanooga, Tennessee, 37404
Recruiting
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
Chattanooga, Tennessee, 37404
Recruiting
Tennessee Oncology, PLLC - Chattanooga East
Chattanooga, Tennessee, 37421
Recruiting
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, 63376
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Recruiting
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, 44195
Recruiting
New York Oncology Hematology
Clifton Park, New York, 12065
Recruiting
MSK Commack
Commack, New York, 11725
Not yet recruiting
Tennessee Oncology, PLLC- Cookeville
Cookeville, Tennessee, 38501
Recruiting
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
Recruiting
Smilow Cancer Hospital - Derby
Derby, Connecticut, 06418
Recruiting
Tennessee Oncology, PLLC - Dickson
Dickson, Tennessee, 37055
Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
Recruiting
City of Hope Investigational Drug Services (IDS)
Duarte, California, 91010
Recruiting
Duke University Medical Center (location of scans)
Durham, North Carolina, 27710
Recruiting
Duke University Medical Center - Duke University Hospital (location of scans)
Durham, North Carolina, 27710
Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Recruiting
Duke University
Durham, North Carolina, 27713
Recruiting
Eye Associates Northwest - Edmonds Clinic
Edmonds, Washington, 98026
Recruiting
UC San Diego Medical Center - Encinitas
Encinitas, California, 92024
Recruiting
UCLA Hematology/Oncology - Encino
Encino, California, 91436
Recruiting
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Recruiting
Smilow Cancer Hospital - Fairfield
Fairfield, Connecticut, 06824
Recruiting
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703
Recruiting
Siteman Cancer Center - North County
Florissant, Missouri, 63031
Recruiting
Tennessee Oncology, PLLC - Franklin
Franklin, Tennessee, 37067
Recruiting
Tennessee Oncology, PLLC - Proton Center
Franklin, Tennessee, 37067
Recruiting
Tennessee Oncology, PLLC - Gallatin
Gallatin, Tennessee, 37066
Recruiting
Smilow Cancer Hospital - Greenwich
Greenwich, Connecticut, 06830
Recruiting
Smilow Cancer Hospital - Guilford
Guilford, Connecticut, 06437
Recruiting
Texas Oncology - Central/South Texas
Harlingen, Texas, 78550
Recruiting
MSK Westchester
Harrison, New York, 10604
Not yet recruiting
Tennessee Oncology, PLLC - Hendersonville
Hendersonville, Tennessee, 37075
Recruiting
Texas Oncology - Gulf Coast
Houston, Texas, 77024
Recruiting
Texas Oncology - Gulf Coast
Houston, Texas, 77054
Recruiting
UCLA Hematology/Oncology - Irvine
Irvine, California, 92604
Recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Recruiting
UCI Health - Irvine Infusion Pharmacy ACC
Irvine, California, 92612
Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Recruiting
City of Hope Investigational Drug Service (IDS)
Irvine, California, 92618
Recruiting
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063
Recruiting
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063
Recruiting
Eye Associates Northwest - Kirkland Clinic
Kirkland, Washington, 98034
Recruiting
UC San Diego Koman Family Outpatient Pavilion
La Jolla, California, 92037
Recruiting
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, 92037
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92037
Recruiting
UC San Diego Shiley Eye Institute
La Jolla, California, 92037
Recruiting
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, 92037
Recruiting
Viterbi Family Department of Ophthalmology
La Jolla, California, 92037
Recruiting
UCLA Hematology Oncology- Laguna Hills
Laguna Hills, California, 92653
Recruiting
Tennessee Oncology, PLLC - Lebanon
Lebanon, Tennessee, 37090
Recruiting
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
Recruiting
City of Hope-Long Beach (ELM)
Long Beach, California, 90813
Recruiting
Investigational Drug Service
Long Island City, New York, 11101
Not yet recruiting
START Los Angeles, LLC
Los Angeles, California, 90025
Recruiting
Los Angeles Cancer Network - Century City
Los Angeles, California, 90067
Recruiting
(IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095
Recruiting
UCLA Hematology/Oncology
Los Angeles, California, 90095
Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457
Recruiting
UCLA Hematology/Oncology - Marina del Rey
Marina del Rey, California, 90292
Recruiting
Texas Oncology - Central/South Texas
McAllen, Texas, 78503
Recruiting
MSK Monmouth
Middletown, New Jersey, 07748
Not yet recruiting
MSK Bergen
Montvale, New Jersey, 07645
Not yet recruiting
Tennessee Oncology, PLLC - Mount Juliet
Mount Juliet, Tennessee, 37122
Recruiting
Tennessee Oncology, PLLC - Murfreesboro
Murfreesboro, Tennessee, 37129
Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Recruiting
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology
Nashville, Tennessee, 37203
Recruiting
Tennessee Oncology, PLLC - Investigational Drug Services
Nashville, Tennessee, 37203
Recruiting
Tennessee Oncology, PLLC - Saint Thomas West
Nashville, Tennessee, 37205
Recruiting
Tennessee Oncology, PLLC- Skyline
Nashville, Tennessee, 37207
Recruiting
Tennessee Oncology, PLLC- Southern Hills
Nashville, Tennessee, 37211
Recruiting
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, 06510
Recruiting
Yale Eye Center
New Haven, Connecticut, 06510
Recruiting
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, 06510
Recruiting
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511
Recruiting
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
New Haven, Connecticut, 06511
Recruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021
Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Recruiting
Evelyn H. Lauder Breast and Imaging Center (BAIC)
New York, New York, 10065
Not yet recruiting
Memorial Sloan Kettering Cancer Center-Main Campus
New York, New York, 10065
Not yet recruiting
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Not yet recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
Recruiting
Smilow Cancer Hospital - North Haven
North Haven, Connecticut, 06473
Recruiting
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
Recruiting
UC Irvine Health
Orange, California, 92868
Recruiting
UCLA Hematology/Oncology - Pasadena
Pasadena, California, 91105
Recruiting
Texas Oncology - Gulf Coast
Pearland, Texas, 77584
Recruiting
UCLA Hematology Oncology - Porter Ranch
Porter Ranch, California, 91326
Recruiting
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213
Recruiting
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227
Recruiting
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609
Recruiting
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
Recruiting
Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)
Raleigh, North Carolina, 27609
Recruiting
Tennessee Oncology, PLLC- Ringgold
Ringgold, Georgia, 30736
Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Recruiting
Highlands Oncology Group, PA
Rogers, Arkansas, 72758
Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Salem, Virginia, 24153
Recruiting
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, 84112
Recruiting
UC San Diego Medical Center - Bankers Hill
San Diego, California, 92101
Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, 92103
Recruiting
UC San Diego Medical Center- Hillcrest
San Diego, California, 92103
Recruiting
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, 92127
Recruiting
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, 93401
Recruiting
UCLA Hematology/Oncology- Santa Barbara
Santa Barbara, California, 93101
Recruiting
UCLA Hematology/Oncology- Santa Monica
Santa Monica, California, 90404
Recruiting
Eye Associates Northwest - Ballard Clinic and Surgery Center
Seattle, Washington, 98104
Recruiting
Eye Associates Northwest - First Hill Clinic
Seattle, Washington, 98104
Recruiting
Harborview Medical Center
Seattle, Washington, 98104
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Recruiting
Eye Associates Northwest - Northgate Clinic
Seattle, Washington, 98125
Recruiting
University Of Washington Medical Center
Seattle, Washington, 98195
Recruiting
Tennessee Oncology, PLLC -Shelbyville
Shelbyville, Tennessee, 37160
Recruiting
Memorial Hospital
Shiloh, Illinois, 62269
Recruiting
Siteman Cancer Center - Shiloh
Shiloh, Illinois, 62269
Recruiting
Tennessee Oncology, PLLC - Smyrna
Smyrna, Tennessee, 37167
Recruiting
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
Recruiting
Oncology Associates of Oregon, P.C.
Springfield, Oregon, 97477
Recruiting
Siteman Cancer Center
St Louis, Missouri, 63108
Recruiting
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Recruiting
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Recruiting
Siteman Cancer Center - South County
St Louis, Missouri, 63129
Recruiting
Smilow Cancer Hospital - Long Ridge
Stamford, Connecticut, 06902
Recruiting
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479
Recruiting
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380
Recruiting
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223
Recruiting
UCLA Hematology/Oncology - Torrance
Torrance, California, 90505
Recruiting
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, 06835
Recruiting
MSK Nassau
Uniondale, New York, 11553
Not yet recruiting
City of Hope UPLAND
Upland, California, 91786
Recruiting
UCLA Hematology/Oncology - Santa Clarita
Valencia, California, 91355
Recruiting
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Recruiting
UCLA Hematology/Oncology - Ventura
Ventura, California, 93003
Recruiting
UC San Diego Medical Center - Vista
Vista, California, 92081
Recruiting
Texas Oncology - Central/South Texas
Waco, Texas, 76712
Recruiting
Sibley Memorial Hospital Pharmacy Department
Washington D.C., District of Columbia, 20016
Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Recruiting
Texas Oncology - Gulf Coast
Webster, Texas, 77598
Recruiting
Texas Oncology - Central South
Weslaco, Texas, 78596
Recruiting
UCLA Hematology/Oncology - Westlake
Westlake Village, California, 91361
Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382
Recruiting

Other trials in United States

Spain6 sites, 6 recruiting

Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [barcelona], 08003
Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], 08041
Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Recruiting

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China4 sites, 4 recruiting

Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Recruiting
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, 315010
Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Recruiting

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Puerto Rico4 sites, 4 recruiting

Pan American Center for Oncology Trials, LLC - Manati Office
Manati, 00674
Recruiting
Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez, 00680
Recruiting
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, 00935
Recruiting
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
Recruiting

Other trials in Puerto Rico

Australia3 sites, 3 recruiting

Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066
Recruiting
Monash Health
Clayton, Victoria, 3168
Recruiting
Macquarie University
North Ryde, New South Wales, 2109
Recruiting

Other trials in Australia

Japan3 sites, 3 recruiting

National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Recruiting
Keio university hospital
Shinjuku-ku, Tokyo, 1608582
Recruiting
Yamagata University Hospital
Yamagata, 990-9585
Recruiting

Other trials in Japan

About this study

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

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: Urothelial Cancer, Advanced/Metastatic Urothelial Cancer, Urothelial Carcinoma
Being tested: PF-08634404, Enfortumab Vedotin
Keywords: urothelial cancer, metastatic urothelial cancer, locally advanced urothelial cancer, bladder cancer, urothelial carcinoma, PD-1, VEGF
Medical subject headings: Carcinoma, Transitional Cell, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-08634404Biological
Also called SSGJ-707
Concentrate for solution for Infusion.
Enfortumab VedotinBiological
Also called PF-08046042, ASG-22CE, PADCEV
Powder for concentrate for solution for infusion

Study groups in NCT07421700
Study group	Role	What they receive
Cohort A	Experimental	Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy. Receives: Biological: PF-08634404
Cohort B	Experimental	Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin Receives: Biological: PF-08634404; Biological: Enfortumab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

Confirmed Objective Response Rate (ORR) by investigator
ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator.
Measured: Up to approximately 3 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention.
Measured: Through 90 days after the last study intervention; Up to approximately 3 years
Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B
The number of participants who experienced DLTs in participants receiving PF-08634404 in combination with EV.
Measured: Through 90 days after the last study intervention; Up to approximately 3 years

Secondary outcomes (6)

Duration of Response (DOR) per RECIST v1.1 by investigator
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Measured: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: Up to approximately 3 years
Overall Survival (OS)
Overall survival defined as the time from the date of C1D1 to the date of death due to any cause.
Measured: Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0)
Measured: Through 90 days after the last study intervention; Up to approximately 3 years
Pharmacokinetics (PK): Serum concentration of PF-08634404
To characterize the pharmacokinetics (PK) of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC.
Measured: Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
To evaluate the immunogenicity of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC.
Measured: Up to 37 days after the last dose of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 202625 Sep 2028

First posted19 Feb 2026
Study start11 Mar 2026
Primary completion28 Dec 2027 (estimated)
Study completion25 Sep 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Urothelial CancerStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 132 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07421700
Sponsor's protocol ID: C6461006
Other IDs: 2025-523523-21-00, Symbiotic-GU-06, 2025
Status last verified: Oct 2026
First submitted: 12 Feb 2026
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Interested in taking part?

Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer
Localized Renal Pelvis and Ureter Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruitingPhase 2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma
Active, not recruitingPhase 3
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
Metastatic Bladder Urothelial Carcinoma, Metastatic Urothelial Carcinoma

All Urothelial Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07421700
Acronym / sponsor ID: C6461006
Conditions: Urothelial Cancer, Advanced/Metastatic Urothelial Cancer, Urothelial Carcinoma
Keywords: urothelial cancer, metastatic urothelial cancer, locally advanced urothelial cancer, bladder cancer, urothelial carcinoma, PD-1, VEGF
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 132 participants (estimated)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Astellas Pharma Inc
Study start: 11 Mar 2026 (actual)
Primary completion: 28 Dec 2027 (estimated)
Study completion: 25 Sep 2028 (estimated)
First posted: 19 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort A	Experimental	Biological: PF-08634404Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy.
Cohort B	Experimental	Biological: PF-08634404, Biological: Enfortumab VedotinParticipants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-08634404Also: SSGJ-707Concentrate for solution for Infusion.	Biological	Cohort A, Cohort B
Enfortumab VedotinAlso: PF-08046042, ASG-22CE, PADCEVPowder for concentrate for solution for infusion	Biological	Cohort B

Primary outcome

Confirmed Objective Response Rate (ORR) by investigator
Time frame: Up to approximately 3 years
ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator.
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Through 90 days after the last study intervention; Up to approximately 3 years
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention.
Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B
Time frame: Through 90 days after the last study intervention; Up to approximately 3 years
The number of participants who experienced DLTs in participants receiving PF-08634404 in combination with EV.

6 secondary outcomes

Duration of Response (DOR) per RECIST v1.1 by investigator
Time frame: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Through 90 days after the last study intervention; Up to approximately 3 years
Pharmacokinetics (PK): Serum concentration of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
Time frame: Up to 37 days after the last dose of treatment

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Pfizer CT.gov Call Center study director

Pfizer

184 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PF-08634404 and Enfortumab Vedotin in people with Urothelial Cancer and Advanced/Metastatic Urothelial Cancer, run by Pfizer at 184 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Spain, China, Puerto Rico, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (ORR) by investigator (time frame: Up to approximately 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07421700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.