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

Conditions

• Advanced/Metastatic Urothelial Cancer
• Urothelial Cancer
• Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-08634404 — BIOLOGICAL
  Concentrate for solution for Infusion.
• Enfortumab Vedotin — BIOLOGICAL
  Powder for concentrate for solution for infusion

Study Details

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.

Key Dates

Start date

Mar 11, 2026

Status verified

Jun 2026

Primary completion

Dec 6, 2027

Completion

Sep 5, 2028

Study Design

Enrollment

132 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A
  Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy.
• Experimental: Cohort B
  Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) by investigator [ Time Frame: Up to approximately 3 years ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (39)

Find similar trials in Fayetteville, AR

Related Studies

• Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
  PHASE1/PHASE2 · Recruiting · Noah Hahn, M.D. · Phoenix, Arizona
• SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
  Recruiting · Massive Bio, Inc. · Birmingham, Alabama
• A Multicenter Cancer Biospecimen Collection Study
  Recruiting · Cofactor Genomics, Inc. · San Francisco, California
• An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
  Recruiting · University of Texas Southwestern Medical Center · Dallas, Texas