NCT07421700From ClinicalTrials.govRecruiting

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

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

Urothelial Cancer
Advanced/Metastatic Urothelial Cancer
Urothelial Carcinoma

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 132
Started: 11 March 2026
Main results due: 28 December 2027
Study sites: 173
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(173)

Highlands Oncology Group, PA
Fayetteville, Arkansas, United States
Recruiting
Highlands Oncology Group, PA
Rogers, Arkansas, United States
Recruiting
Highlands Oncology Group, PA
Springdale, Arkansas, United States
Recruiting
UCLA Hematology/Oncology - Alhambra
Alhambra, California, United States
Recruiting
UCLA Hematology/Oncology - Atascadero
Atascadero, California, United States
Recruiting
UCLA Hematology/Oncology - Beverly Hills
Beverly Hills, California, United States
Recruiting
UCLA Hematology/Oncology - Burbank
Burbank, California, United States
Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Recruiting
City of Hope Investigational Drug Services (IDS)
Duarte, California, United States
Recruiting
UC San Diego Medical Center - Encinitas
Encinitas, California, United States
Recruiting
UCLA Hematology/Oncology - Encino
Encino, California, United States
Recruiting
UCLA Hematology/Oncology - Irvine
Irvine, California, United States
Recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Recruiting
UCI Health - Irvine Infusion Pharmacy ACC
Irvine, California, United States
Recruiting
City of Hope at Irvine Lennar
Irvine, California, United States
Recruiting
City of Hope Investigational Drug Service (IDS)
Irvine, California, United States
Recruiting
UC San Diego Koman Family Outpatient Pavilion
La Jolla, California, United States
Recruiting
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
UC San Diego Shiley Eye Institute
La Jolla, California, United States
Recruiting
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, United States
Recruiting
Viterbi Family Department of Ophthalmology
La Jolla, California, United States
Recruiting
UCLA Hematology Oncology- Laguna Hills
Laguna Hills, California, United States
Recruiting
City of Hope-Long Beach (ELM)
Long Beach, California, United States
Recruiting
START Los Angeles, LLC
Los Angeles, California, United States
Not yet recruiting
Los Angeles Cancer Network - Century City
Los Angeles, California, United States
Not yet recruiting
(IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States
Recruiting
UCLA Hematology/Oncology
Los Angeles, California, United States
Recruiting
UCLA Hematology/Oncology - Marina del Rey
Marina del Rey, California, United States
Recruiting
UC Irvine Health
Orange, California, United States
Recruiting
UCLA Hematology/Oncology - Pasadena
Pasadena, California, United States
Recruiting
UCLA Hematology Oncology - Porter Ranch
Porter Ranch, California, United States
Recruiting
UC San Diego Medical Center - Bankers Hill
San Diego, California, United States
Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, United States
Recruiting
UC San Diego Medical Center- Hillcrest
San Diego, California, United States
Recruiting
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, United States
Recruiting
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, United States
Recruiting
UCLA Hematology/Oncology- Santa Barbara
Santa Barbara, California, United States
Recruiting
UCLA Hematology/Oncology- Santa Monica
Santa Monica, California, United States
Recruiting
UCLA Hematology/Oncology - Torrance
Torrance, California, United States
Recruiting
City of Hope UPLAND
Upland, California, United States
Recruiting
UCLA Hematology/Oncology - Santa Clarita
Valencia, California, United States
Recruiting
UCLA Hematology/Oncology - Ventura
Ventura, California, United States
Recruiting
UC San Diego Medical Center - Vista
Vista, California, United States
Recruiting
UCLA Hematology/Oncology - Westlake
Westlake Village, California, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
Recruiting
Smilow Cancer Hospital - Derby
Derby, Connecticut, United States
Recruiting
Smilow Cancer Hospital - Fairfield
Fairfield, Connecticut, United States
Recruiting
Smilow Cancer Hospital - Greenwich
Greenwich, Connecticut, United States
Recruiting
Smilow Cancer Hospital - Guilford
Guilford, Connecticut, United States
Recruiting
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, United States
Recruiting
Yale Eye Center
New Haven, Connecticut, United States
Recruiting
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States
Recruiting
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
New Haven, Connecticut, United States
Recruiting
Smilow Cancer Hospital - North Haven
North Haven, Connecticut, United States
Recruiting
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Recruiting
Smilow Cancer Hospital - Long Ridge
Stamford, Connecticut, United States
Recruiting

Showing 60 of 173 sites — filter to narrow it down. 171 of the 173 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07421700. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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