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Symbiotic-GU-06: A Study for Urothelial Cancer

This study is testing a new medicine called PF-08634404, either alone or with enfortumab vedotin, for adults with locally advanced or metastatic urothelial cancer (bladder cancer that has spread). The main goals are to see how many people respond to the treatment (Objective Response Rate), to track any side effects (adverse events), and to see if there are any dose-limiting toxicities. You can join if you are at least 18 years old and have this type of cancer. The study aims to enroll 132 participants to learn about the safety and effectiveness of PF-08634404.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 132 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for side effects for 90 days after your last study treatment, and for up to approximately 3 years for overall response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07421700

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pfizer
~132 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PF-08634404Enfortumab Vedotin

At a glance

Recruiting sites
133 of 153 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Confirmed Objective Response Rate (ORR) by investigator
Measured over Up to approximately 3 years
+2 more outcomes measured

Conditions

Urothelial Cancer
Advanced/Metastatic Urothelial Cancer
Urothelial Carcinoma

Explore related trials

Urothelial Carcinoma

Where it's being run

153 sites across 31 states
California37
Tennessee23
Texas16
Washington9
North Carolina8
Missouri7
Virginia7
Maryland5

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • Confirmed Objective Response Rate (ORR) by investigatorUp 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)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 BThrough 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.