RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT07421700Sponsor: PfizerLast updated: 2026-06-04

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.

Arms & interventions

BiologicalPF-08634404
Concentrate for solution for Infusion.
BiologicalEnfortumab Vedotin
Powder for concentrate for solution for infusion

Outcome measures

Primary

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.
Time frame: 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.
Time frame: 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.
Time frame: Through 90 days after the last study intervention; Up to approximately 3 years

Secondary

Duration of Response (DOR) per RECIST v1.1 by investigator
Time frame: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Through 90 days after the last study intervention; Up to approximately 3 years
Pharmacokinetics (PK): Serum concentration of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
Time frame: Up to 37 days after the last dose of treatment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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.

Study locations (39)

Highlands Oncology Group, PA

Fayetteville, Arkansas, 72703

Recruiting

Highlands Oncology Group, PA

Rogers, Arkansas, 72758

Recruiting

Highlands Oncology Group, PA

Springdale, Arkansas, 72762

Recruiting

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

Duarte, California, 91010

Recruiting

City of Hope Investigational Drug Services (IDS)

Duarte, California, 91010

Recruiting

City of Hope at Irvine Lennar

Irvine, California, 92618

Recruiting

City of Hope Investigational Drug Service (IDS)

Irvine, California, 92618

Recruiting

City of Hope-Long Beach (ELM)

Long Beach, California, 90813

Recruiting

City of Hope UPLAND

Upland, California, 91786

Recruiting

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, 80012

Recruiting

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80218

Recruiting

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, 80124

Recruiting

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360

Recruiting

New York Oncology Hematology

Albany, New York, 12206

Recruiting

New York Oncology Hematology

Clifton Park, New York, 12065

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting

Texas Oncology - Central/South Texas

Austin, Texas, 78705

Recruiting

Texas Oncology - Central/South Texas

Austin, Texas, 78731

Recruiting

Texas Oncology - Central/South Texas

Austin, Texas, 78745

Recruiting

Texas Oncology - Central South

Austin, Texas, 78758

Recruiting

Texas Oncology - Gulf Coast

Beaumont, Texas, 77702

Recruiting

Texas Oncology - Central/South Texas

Harlingen, Texas, 78550

Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77024

Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77054

Recruiting

US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063

Recruiting

Texas Oncology - Central/South Texas

McAllen, Texas, 78503

Recruiting

Texas Oncology - Gulf Coast

Pearland, Texas, 77584

Recruiting

Texas Oncology - Gulf Coast

Sugar Land, Texas, 77479

Recruiting

Texas Oncology - Gulf Coast

The Woodlands, Texas, 77380

Recruiting

Texas Oncology - Central/South Texas

Waco, Texas, 76712

Recruiting

Texas Oncology - Gulf Coast

Webster, Texas, 77598

Recruiting

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

Blacksburg, Virginia, 24060

Recruiting

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031

Recruiting

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

Low Moor, Virginia, 24457

Recruiting

Virginia Oncology Associates

Norfolk, Virginia, 23502

Recruiting

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

Roanoke, Virginia, 24014

Recruiting

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

Salem, Virginia, 24153

Recruiting

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

Wytheville, Virginia, 24382

Recruiting