臨床研究等提出・公開システム

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

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Pending

Dec. 24, 2025

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

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.

Both

*Urothelial Cancer
*Advanced/Metastatic Urothelial Cancer
*Urothelial Carcinoma

*Biological: PF-08634404
-Concentrate for solution for Infusion.
-Other Names:
#SSGJ-707
*Biological: Enfortumab Vedotin
-Powder for concentrate for solution for infusion
-Other Names:
#PF-08046042
#ASG-22CE
#PADCEV

*Confirmed Objective Response Rate (ORR) by investigator [Time Frame: Up to approximately 3 years]
-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.
*Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Through 90 days after the last study intervention; Up to approximately 3 years]
-AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention.
*Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B [Time Frame: Through 90 days after the last study intervention; Up to approximately 3 years]
-The number of participants who experienced DLTs in participants receiving PF-08634404 in combination with EV.

*Duration of Response (DOR) per RECIST v1.1 by investigator [Time Frame: Up to approximately 3 years]
-DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
*Progression Free Survival (PFS) per RECIST v1.1 by investigator [Time Frame: Up to approximately 3 years]
-Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
*Overall Survival (OS) [Time Frame: Up to approximately 3 years]
-Overall survival defined as the time from the date of C1D1 to the date of death due to any cause.
*Number of Participants With Clinical Laboratory Abnormalities [Time Frame: Through 90 days after the last study intervention; Up to approximately 3 years]
-Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0)
*Pharmacokinetics (PK): Serum concentration of PF-08634404 [Time Frame: Up to 37 days after the last dose of treatment]
-To characterize the pharmacokinetics (PK) of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC.
*Incidence of Anti-Drug Antibody (ADA) against PF-08634404 [Time Frame: Up to 37 days after the last dose of treatment]
-To evaluate the immunogenicity of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC.

Feb. 03, 2026

No

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

none