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

Phase 2RecruitingNCT07421700

Pfizer132 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

NOT_YET_RECRUITING

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

NOT_YET_RECRUITING

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States

NOT_YET_RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

Duration of Response (DOR) per RECIST v1.1 by investigator

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.

Time frame: Up to approximately 3 years

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

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.

Time frame: Up to approximately 3 years

Overall Survival (OS)

Overall survival defined as the time from the date of C1D1 to the date of death due to any cause.

Time frame: Up to approximately 3 years

Number of Participants With Clinical Laboratory Abnormalities

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0)

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

Pharmacokinetics (PK): Serum concentration of PF-08634404

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.

Time frame: Up to 37 days after the last dose of treatment

Incidence of Anti-Drug Antibody (ADA) against PF-08634404

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.

Time frame: Up to 37 days after the last dose of treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (25)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts