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

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052667 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH BLADDER CANCER

Phase 1 Interventional Pfizer · NCT07206225

This study will test whether the new medicine PF-08052667, alone or with BCG and/or sasanlimab, helps adults with high-risk non-muscle invasive bladder cancer that has come back or not responded to standard treatment.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment294 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsradiation, sasanlimab
Locations47 sites (Birmingham, Alabama and 46 other locations)
Trial IDNCT07206225 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with high-risk non-muscle invasive urothelial carcinoma (CIS with or without Ta/T1), who are BCG-exposed or unresponsive or are ineligible/refuse cystectomy, have ECOG 0–1, and can provide recent tumor tissue.

Not a fit: Patients with muscle-invasive bladder cancer, those receiving other anticancer therapy, or those unable to provide required tissue or attend the Birmingham site visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the medicine could provide a new bladder-preserving treatment option for patients with high-risk NMIBC who have failed or cannot receive standard therapies.

How similar studies have performed: Other intravesical immunotherapies and checkpoint inhibitor combinations have shown some promising early signals in NMIBC, but PF-08052667 itself is a novel agent being tested in humans.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-muscle Invasive Bladder CancerNMIBCNon-Muscle Invasive Bladder CancerBladder CancerBladder TumorsBladder NeoplasmsMalignant Tumor of Urinary BladderUrinary Bladder Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.