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PF-08634404 alone or with enfortumab vedotin for advanced urothelial (bladder) cancer

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

Phase1; Phase2 Interventional Pfizer · NCT07421700

This trial will try PF-08634404 by itself or together with enfortumab vedotin to see if it is safe and helps adults with advanced or metastatic urothelial (bladder) cancer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment132 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsenfortumab
Locations40 sites (Fayetteville, Arkansas and 39 other locations)
Trial IDNCT07421700 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 trial tests the investigational drug PF-08634404 alone or in combination with enfortumab vedotin in adults with locally advanced or metastatic urothelial carcinoma. Participants who have already received prior therapy get PF-08634404 alone (Cohort A), while treatment-naive participants receive PF-08634404 plus enfortumab vedotin (Cohort B). The study examines safety, drug pharmacokinetics, tumor response by RECIST v1.1, and changes in cancer-related biomarkers. Eligible patients must have measurable disease, ECOG performance status 0–1, and adequate organ function, and will be treated at participating Highlands Oncology Group sites in Arkansas.

Who should consider this trial

Good fit: Adults with locally advanced or metastatic urothelial carcinoma who have measurable disease, ECOG 0–1, adequate organ function, and who meet cohort-specific prior-treatment criteria are the intended participants.

Not a fit: Patients with active central nervous system metastases, recent other malignancies, uncontrolled autoimmune disease, poor organ function, or ECOG performance status above 1 are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If successful, the regimen could provide a new treatment option that shrinks tumors or prolongs disease control for people with advanced urothelial cancer.

How similar studies have performed: Enfortumab vedotin is an approved therapy with demonstrated benefit in urothelial cancer, but PF-08634404 is experimental and combining it with enfortumab vedotin is a novel approach that is unproven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Fayetteville, Arkansas and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urothelial CancerAdvanced/Metastatic Urothelial CancerUrothelial Carcinomaurothelial cancermetastatic urothelial cancerlocally advanced urothelial cancerbladder cancerurothelial carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.