Brief Title: A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with dose limiting toxicities (DLTs) in dose escalation in Part 1 and Part 2 participants only

Primary Outcome 1 - Timeframe: Day of first dose (Day 1) Up to 21 days

Primary Outcome 2 - Measure: Number of participants with adverse events (AEs) in Part 1 and Part 2 participants only

Primary Outcome 2 - Timeframe: From the first day through 30-37 days after the last study treatment

Primary Outcome 3 - Measure: Number of participants with laboratory abnormalities in Part 1 and Part 2 participants only

Primary Outcome 3 - Timeframe: up to approximately 2 years

Primary Outcome 4 - Measure: Recurrence-free survival (RFS) in Part 3 participants only

Primary Outcome 4 - Timeframe: From the first day through 30-37 days after the last study treatment

Primary Outcome 5 - Measure: Event-free survival (EFS) in Part 3 participants only

Primary Outcome 5 - Timeframe: up to approximately 2 years

CONDITION

• Non-muscle Invasive Bladder Cancer

ELIGIBILITY

INCLUSION CRITERIA:
1. 18 years of age or older (or the minimum age of consent per local regulations)

- 2. Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder defined according to the WHO grading system as carcinoma in situ (CIS), with or without concurrent T1/Ta papillary disease. Note: High-grade T1/Ta papillary disease, in the absence of CIS, may be eligible for certain cohorts in Part 2 and 3

- 3. BCG unresponsive and BCG-exposed cohorts should have persistent or recurrent disease after receiving at least 5 out of 6 doses of the BCG induction therapy.

- 4. Have refused or are ineligible or not appropriate for radical cystectomy

- 5. Tissue Requirement: Available tumor tissue within the last 6 months. On-treatment tumor biopsy is optional, unless mandated based on emerging data, or participating in the Biomarker Cohort, or for disease assessment

- 6. ECOG PS 0 or 1
EXCLUSION CRITERIA:
1. Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed

- 2. Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol

- 3. Participants with active, uncontrolled infection as specified in the protocol

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