Testing PF-08052667 for high-risk non-muscle invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label study uses a multi-part design to first escalate doses of PF-08052667 alone and then test combinations with BCG and/or sasanlimab to define safety and appropriate dosing. Eligible adults have high-risk non-muscle invasive urothelial carcinoma (including carcinoma in situ) who are BCG-exposed or unresponsive, or who cannot or will not undergo cystectomy. The study collects tumor tissue and may include optional on-treatment biopsies and biomarker assessments to understand biological effects. Primary focus is safety, tolerability, and identifying dose levels for future efficacy testing.

Why it matters

Who can join: the full rules

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

Where it's running

• The Kirklin Clinic of UAB Hospital
  Birmingham, Alabama, United States Recruiting
• UAB Infusion Therapy Extended Care Clinic (ECC)
  Birmingham, Alabama, United States Recruiting
• The University of Alabama at Birmingham Investigation Drug Services Pharmacy
  Birmingham, Alabama, United States Recruiting
• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Moffitt Cancer Center at SouthShore
  Ruskin, Florida, United States Recruiting
• Moffitt Cancer Center - International Plaza
  Tampa, Florida, United States Recruiting

+19 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

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• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

  This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.

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• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

  This study tests whether patients who have become tumor-free after a systemic immunotherapy-based bladder-sparing treatment can safely stop therapy and instead be watched closely.

  Recruiting at 4 sites Phase 2 Tianjin Medical University Second Hospital · Tianjin and 3 other locations · NCT07625527

• Comparing CT and MRI with VI-RADS for Bladder Cancer Staging

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• How bladder microbes and immune signals affect lower urinary tract health

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  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07494864

• Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

  This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).

  Recruiting at 14 sites Phase 2 Lepu Biopharma Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT07283835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.