Recruiting NCT07421700

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

Phase I / Phase II Interventional Urothelial Cancer Advanced/Metastatic Urothelial Cancer Urothelial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: PF-08634404, Enfortumab Vedotin.
Who it may be relevant to: Registry conditions: Urothelial Cancer, Advanced/Metastatic Urothelial Cancer, Urothelial Carcinoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, China, Japan, Puerto Rico +1
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

Biological PF-08634404
Concentrate for solution for Infusion.
Biological Enfortumab Vedotin
Powder for concentrate for solution for infusion

Primary outcome measures

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

Secondary outcome measures (6)

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Sequential
Masking: Open label
Primary purpose: Treatment