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

NCT07421700 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: C64610062025-523523-21-00Symbiotic-GU-06
• Study Type: interventional
• Target: 132
• Locations: 5 countries
• Sites: 50

Brief 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

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  Up to approximately 3 years

• Progression Free Survival (PFS) per RECIST v1.1 by investigator

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 3 years

• Number of Participants With Clinical Laboratory Abnormalities

  Through 90 days after the last study intervention; Up to approximately 3 years

• Pharmacokinetics (PK): Serum concentration of PF-08634404

  Up to 37 days after the last dose of treatment

Study Arms (2)

Cohort A

EXPERIMENTAL

Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy.

Biological: PF-08634404

Cohort B

EXPERIMENTAL

Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin

Biological: PF-08634404; Biological: Enfortumab Vedotin

Interventions

PF-08634404 BIOLOGICAL

Concentrate for solution for Infusion.

Also known as: SSGJ-707

Cohort A; Cohort B

Enfortumab Vedotin BIOLOGICAL

Powder for concentrate for solution for infusion

Also known as: PF-08046042, ASG-22CE, PADCEV

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• Astellas Pharma Inc: collaborator

Study Sites (50)

Highlands Oncology Group, PA

Fayetteville, Arkansas, 72703, United States

RECRUITING

Highlands Oncology Group, PA

Rogers, Arkansas, 72758, United States

RECRUITING

Highlands Oncology Group, PA

Springdale, Arkansas, 72762, United States

RECRUITING

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, 91010, United States

RECRUITING

City of Hope Investigational Drug Services (IDS)

Duarte, California, 91010, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

City of Hope Investigational Drug Service (IDS)

Irvine, California, 92618, United States

RECRUITING

City of Hope-Long Beach (ELM)

Long Beach, California, 90813, United States

RECRUITING

City of Hope UPLAND

Upland, California, 91786, United States

RECRUITING

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, 80012, United States

RECRUITING

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80218, United States

RECRUITING

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, 80124, United States

RECRUITING

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

RECRUITING

New York Oncology Hematology

Albany, New York, 12206, United States

RECRUITING

New York Oncology Hematology

Clifton Park, New York, 12065, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Central/South Texas

Austin, Texas, 78705, United States

RECRUITING

Texas Oncology - Central/South Texas

Austin, Texas, 78731, United States

RECRUITING

Texas Oncology - Central/South Texas

Austin, Texas, 78745, United States

RECRUITING

Texas Oncology - Central South

Austin, Texas, 78758, United States

RECRUITING

Texas Oncology - Gulf Coast

Beaumont, Texas, 77702, United States

RECRUITING

Texas Oncology - Central/South Texas

Harlingen, Texas, 78550, United States

RECRUITING

Texas Oncology - Gulf Coast

Houston, Texas, 77024, United States

RECRUITING

Texas Oncology - Gulf Coast

Houston, Texas, 77054, United States

RECRUITING

US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063, United States

RECRUITING

Texas Oncology - Central/South Texas

McAllen, Texas, 78503, United States

RECRUITING

Texas Oncology - Gulf Coast

Pearland, Texas, 77584, United States

RECRUITING

Texas Oncology - Gulf Coast

Sugar Land, Texas, 77479, United States

RECRUITING

Texas Oncology - Gulf Coast

The Woodlands, Texas, 77380, United States

RECRUITING

Texas Oncology - Central/South Texas

Waco, Texas, 76712, United States

RECRUITING

Texas Oncology - Gulf Coast

Webster, Texas, 77598, United States

RECRUITING

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Blacksburg, Virginia, 24060, United States

RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

RECRUITING

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Low Moor, Virginia, 24457, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States

RECRUITING

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Salem, Virginia, 24153, United States

RECRUITING

Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care

Wytheville, Virginia, 24382, United States

RECRUITING

Macquarie University

North Ryde, New South Wales, 2109, Australia

RECRUITING

Icon Cancer Centre Wesley

Auchenflower, Queensland, 4066, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

NOT YET RECRUITING

Beijing Cancer hospital

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Keio university hospital

Shinjuku-ku, Tokyo, 1608582, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

RECRUITING

Yamagata University Hospital

Yamagata, 990-9585, Japan

RECRUITING

Pan American Center for Oncology Trials, LLC - Manati Office

Manati, 00674, Puerto Rico

RECRUITING

Pan American Center for Oncology Trials, LLC - Mayaguez Office

Mayagüez, 00680, Puerto Rico

RECRUITING

Hospital Oncologico Dr. Isaac Gonzalez-Martinez

Rio Piedras, 00935, Puerto Rico

RECRUITING

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935, Puerto Rico

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms

Interventions

enfortumab vedotin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): December 6, 2027
• Study Completion (Estimated): September 5, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); US (39); PR (4); JP (3); CN (1)