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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Confirmed Objective Response Rate (ORR) by investigator

Primary Outcome 1 - Timeframe: Up to approximately 3 years

Primary Outcome 2 - Measure: Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Primary Outcome 2 - Timeframe: Through 90 days after the last study intervention; Up to approximately 3 years

Primary Outcome 3 - Measure: Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B

Primary Outcome 3 - Timeframe: Through 90 days after the last study intervention; Up to approximately 3 years

CONDITION

• Urothelial Cancer
• Advanced/Metastatic Urothelial Cancer
• Urothelial Carcinoma

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: [email protected]

LOCATION