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

NCT07421700 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-04-20

No results posted yet for this study

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.

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

Interventions

BIOLOGICAL

PF-08634404

Concentrate for solution for Infusion.

BIOLOGICAL

Enfortumab Vedotin

Powder for concentrate for solution for infusion

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2027-12-06
Completion
2028-09-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Japan
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07421700 on ClinicalTrials.gov