> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-the-study-medicine-pf-08052667-in-f1456318-d5a1-4f48-99b2-e5f049cf58eb > Record changed: 2026-10-13 # A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer NCT07206225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) Participants 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) Start date 2025-11-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) Number of sites 68 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Title and summary **Summary** The purpose of this study is to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and/or a medicine called sasanlimab. This study is for adults who have a type of bladder cancer that hasn't spread into the muscle layer of the bladder but is more likely to come back or grow. It includes people whose cancer has come back or hasn't gone away after receiving standard treatments like BCG. It may also include people who, based on their doctor's opinion, cannot receive standard treatments or those treatments are not available to them. The study has three parts: \* Part 1 (monotherapy dose escalation) will test PF-08052667 as a single-agent at increasing dose levels in participants with certain bladder cancer whose disease has worsened on or after standard treatments. \* Part 2 (combination dose escalation) will test PF-08052667 in combination with BCG and/or sasanlimab (fixed dose) in participants with certain bladder cancer whose disease has worsened on or after standard treatments. \* Part 3 (dose optimization and expansion) will further test PF-08052667 as a single agent or in combination with BCG and/or sasanlimab, at the dose(s) based on findings from Part 1 and Part 2 in participants with certain bladder cancer including those who has never received standard treatments. All participants will receive the study drug PF-08052667\. Only participants in Part 2 and Part 3 of the study will also receive BCG and/or sasanlimab. PF-08052667 will be given as an intravesical infusion, which means it will be injected directly into the bladder. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin. For all parts, treatment with study medicines will continue until either a participant has decided to stop taking part in the study or is asked to leave the study for various reasons or up to about 2 years, whichever occurs first. Duration of trial participation for each participant will vary as long-term follow-up will continue after treatment discontinuation until loss to-follow-up or death, or until the study is stopped by the sponsor. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Short title** A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Dates **Completion date** 2033-01-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **First posted** 2025-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Registry last updated** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Primary completion date** 2030-01-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Start date** 2025-11-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Size and sites **Participants** 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Planned participants** 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Number of sites** 68 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Identifiers **Registry ID** NCT07206225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **ClinicalTrials.gov ID** NCT07206225 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Study design **Allocation** Not applicable **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Outcomes ### Primary outcomes 1. Number of participants with dose limiting toxicities (DLTs) in dose escalation in Part 1 and Part 2 participants only Timeframe: Day of first dose (Day 1) Up to 21 days Any AE occurring during the DLT observation period that is attributed to PF-08052667 and not to the underlying disease or other causes is considered a DLT. DLT rate estimated based on data from DLT-evaluable participants during the DLT evaluation period. 2. Number of participants with adverse events (AEs) in Part 1 and Part 2 participants only Timeframe: From the first day through 30-37 days after the last study treatment, up to approximately 2 years AEs as characterized by type, frequency, severity (CTCAE v5.0), seriousness, and relatedness to study drug(s). 3. Number of participants with laboratory abnormalities in Part 1 and Part 2 participants only Timeframe: From the first day through 30-37 days after the last study treatment, up to approximately 2 years Laboratory abnormalities as characterized by type, frequency, severity 4. Recurrence-free survival (RFS) in Part 3 participants only Timeframe: Through end of study and up to approximately 2 years RFS is defined as the time from the first dose until recurrence of high-grade disease, or death due to any cause, whichever occurs first 5. Event-free survival (EFS) in Part 3 participants only Timeframe: Through end of study and up to approximately 2 years EFS is defined as the time from the first dose until the first occurrence of an EFS event including progressive disease, recurrence of high-grade disease, or death due to any cause, whichever occurs first ### Secondary outcomes 1. PK: Maximum Observed Serum Concentration (Cmax) Timeframe: From the first day through 30-37 days after the last study treatment Cmax of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3) 2. PK: Time to Reach Maximum Observed Serum Concentration (Tmax) Timeframe: From the first day through 30-37 days after the last study treatment Tmax of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3) 3. PK: Minimum observed serum concentration (Ctrough) Timeframe: From the first day through 30-37 days after the last study treatment Ctrough of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3) 4. PK: Area under the concentration-time curve (AUC) from time zero to last (AUC from time 0 to AUClast) Timeframe: From the first day through 30-37 days after the last study treatment AUClast of PF-08052667as a monotherapy (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3) 5. PK: Half-life (t1/2) Timeframe: From the first day through 30-37 days after the last study treatment 6. Incidence of Anti-Drug Antibody (ADA): Immunogenicity of PF-08052667 as a single agent (Part 1) and in combination with BCG and/or sasanlimab (Part 2 and Part 3) Timeframe: Through 30-37 days after the last study treatment, up to approximately 2 years Incidence and titers of ADA and neutralizing antibody against PF-08052667 7. Duration of Complete Response (CR) in Part 1 and Part 2 participants only Timeframe: Through end of study and up to approximately 2 years Duration of CR is the time from first documentation of CR until the first occurrence of an Event-free survival (EFS) event 8. Complete Response Rate (CRR) in Part 1 and Part 2 participants only Timeframe: Through end of study and up to approximately 2 years CR rate is defined as the proportion of subjects achieving CR 9. Overall survival (OS) in Part 3 participants only Timeframe: Through end of study approximately 5 years from last participant enrollment Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause 10. Cystectomy-free survival in all Parts Timeframe: Through end of study and up to approximately 2 years Cystectomy-free survival is defined as the time from the first dose until cystectomy or death due to any cause, whichever occurs first 11. Event-free survival (EFS) in Part 1 and Part 2 participants only Timeframe: Through end of study and up to approximately 2 years EFS is defined as the time from the first dose until the first occurrence of an EFS event including progressive disease, recurrence of high-grade disease, or death due to any cause, whichever occurs first 12. Recurrence-free survival (RFS) in Part 1 and Part 2 participants only Timeframe: Through end of study and up to approximately 2 years RFS is defined as the time from the first dose until recurrence of high-grade disease, or death due to any cause, whichever occurs first 13. Rate of cystectomy in all parts Timeframe: Through end of study and up to approximately 2 years Rate of cystectomy is defined as the proportion of participants who had a cystectomy while on study 14. Number of participants with adverse events (AEs) in Part 3 participants only Timeframe: From the first day through 30-37 days after the last study treatment, up to approximately 2 years AEs as characterized by type, frequency, severity (CTCAE v5.0), seriousness, and relatedness to study drug(s) 15. Number of participants with laboratory abnormalities in Part3 participants only Timeframe: From the first day through 30-37 days after the last study treatment, up to approximately 2 years Laboratory abnormalities as characterized by type, frequency, severity Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Sites - The Kirklin Clinic of UAB HospitalBirmingham, United StatesRecruiting - UAB Infusion Therapy Extended Care Clinic (ECC)Birmingham, United StatesRecruiting - The University of Alabama at Birmingham Investigation Drug Services PharmacyBirmingham, United StatesRecruiting - University of Alabama at BirminghamBirmingham, United StatesRecruiting - Moffitt Cancer Center at SouthShoreRuskin, United StatesRecruiting - Moffitt Cancer Center - International PlazaTampa, United StatesRecruiting - Moffitt Cancer Center - McKinley CampusTampa, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - Moffitt McKinley HospitalTampa, United StatesRecruiting - Moffitt Cancer Center at Wesley ChapelWesley Chapel, United StatesRecruiting - Emory University Hospital MidtownAtlanta, United StatesRecruiting - Emory University HospitalAtlanta, United StatesRecruiting - Emory UniversityAtlanta, United StatesRecruiting - Northwestern Memorial HospitalChicago, United StatesNot yet recruiting - Northwestern University - Feinberg School of MedicineChicago, United StatesNot yet recruiting - University of Iowa Health CareIowa City, United StatesRecruiting - The University of Kansas - Clinical Research CenterFairway, United StatesRecruiting - The University of Kansas Hospital Cambridge North Tower AKansas City, United StatesRecruiting - The University of Kansas HospitalKansas City, United StatesRecruiting - The University of Kansas Medical Center Medical Office BuildingKansas City, United StatesRecruiting - The University of Kansas Hospital - Indian Creek CampusOverland Park, United StatesRecruiting - The University of Kansas Cancer Center - WestwoodWestwood, United StatesRecruiting - MSK Basking RidgeBasking Ridge, United StatesRecruiting - MSK MonmouthMiddletown, United StatesRecruiting - MSK BergenMontvale, United StatesRecruiting And 43 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## References - PubMed 42008114 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42008114/) Related publication - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C6001001) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206225) ## Related records ### Drugs (2) - [BCG vaccine](https://trialight.com/data/asset/bcg-vaccine-6209b6c5-8e23-4284-bbce-49f9b521e4df.md) - [Sasanlimab](https://trialight.com/data/asset/sasanlimab-831ba76e-bff4-42a3-b3bd-06b8a73e1d91.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (1) - [Urinary bladder neoplasm](https://trialight.com/data/condition/urinary-bladder-neoplasm-269fb796-5527-5895-bad6-63dc153c3401.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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