PF-08052667 for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how PF-08052667 works for a specific type of bladder cancer that hasn't invaded the muscle but is likely to recur. The study tests this treatment alone or combined with Bacillus Calmette Guerin (BCG, a type of immunotherapy) and sasanlimab (an experimental treatment) to determine the best approach. It suits those whose cancer has returned or worsened after standard treatments or those unable to receive such treatments. Participants will receive the new medicine directly in the bladder, with some also receiving additional injections under the skin. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot take other anti-cancer treatments for bladder cancer while participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that PF-08052667 is still under investigation for safety when used alone. As this is an early-stage study, complete safety information is not yet available. However, being a Phase 1 trial, the primary focus is to assess the drug's safety and identify potential side effects. Participants will receive close monitoring for any unwanted effects.
When combined with BCG and/or sasanlimab, some information is available. Previous studies with sasanlimab and BCG have demonstrated that their combination is generally safe. The side effects were consistent with expectations for these treatments and did not indicate increased risk. For instance, immune-related side effects, typical for such treatments, have been observed.
In summary, while complete safety data on PF-08052667 alone is not yet available, ongoing trials aim to ensure it is well-tolerated. The combination with BCG and sasanlimab has shown a predictable safety profile based on past studies. Participants in this trial will be closely monitored for any side effects to ensure their safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about PF-08052667 for bladder cancer because it offers a fresh approach compared to traditional treatments like chemotherapy and BCG therapy. Unlike the usual treatments, PF-08052667 can be administered directly into the bladder (intravesical instillation), which targets the cancer more precisely and may reduce side effects. Additionally, the combination of PF-08052667 with BCG and/or sasanlimab in some trial arms could enhance the immune response against cancer cells, potentially offering a more effective treatment option. This innovative approach provides hope for improved outcomes in bladder cancer patients.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Research has shown that PF-08052667 is under investigation for its potential to treat bladder cancer unresponsive to standard treatments. In this trial, participants may receive PF-08052667 as monotherapy or combined with other treatments like sasanlimab and BCG. Although limited data exists on PF-08052667's effectiveness alone, the focus remains on understanding its effects in the body. Promising evidence emerges when combined with other treatments. Specifically, one study found that adding sasanlimab to BCG reduced the risk of disease progression by 32%. This suggests that these combinations might help manage bladder cancer that hasn't invaded the muscle layer.15678
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Adults with a type of bladder cancer that hasn't spread into the muscle layer but may recur or grow, including those who've had standard treatments like BCG without success, or can't receive them due to doctor's advice or unavailability.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Monotherapy Dose Escalation
PF-08052667 is tested as a single-agent at increasing dose levels in participants with bladder cancer whose disease has worsened on or after standard treatments.
Combination Dose Escalation
PF-08052667 is tested in combination with BCG and/or sasanlimab in participants with bladder cancer whose disease has worsened on or after standard treatments.
Dose Optimization and Expansion
Further testing of PF-08052667 as a single agent or in combination with BCG and/or sasanlimab at optimized doses based on findings from previous parts.
Follow-up
Participants are monitored for safety and effectiveness after treatment discontinuation until loss to follow-up or death, or until the study is stopped by the sponsor.
What Are the Treatments Tested in This Trial?
Interventions
- BCG
- PF-08052667
- Sasanlimab
Trial Overview
The study tests PF-08052667 alone (Part 1) and in combination with BCG and/or sasanlimab (Parts 2 & 3) for bladder cancer. It explores increasing doses, optimal combinations, and includes patients untreated by standard therapies.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
PF-08052667 will be administered through intravesical instillation at defined dose levels. Dosing schedule is on Day 1, 8 and 15 of a 21-day cycle.
PF-08052667 monotherapy or in combination with BCG and/or sasanlimab at dose levels/schedules for PF-08052667 determined in Parts 1 and 2.
PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1
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Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
A Study to Learn About the Study Medicine PF-08052667 ...
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 ...
Pfizer's Sasanlimab Combination Significantly Improves ...
Pivotal Phase 3 CREST trial results show a 32% reduction in the risk of disease-related events, including high-grade disease recurrence or ...
3.
pfizerclinicaltrials.com
pfizerclinicaltrials.com/find-a-trial/nct07206225-non-muscle-invasive-bladder-cancer-trialClinical Trial for Non-muscle Invasive Bladder Cancer.
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 ...
Sasanlimab plus BCG in BCG-naive, high-risk non-muscle ...
Sasanlimab is the first anti-PD-1 antibody to show a clinically meaningful prolongation of EFS when combined with BCG-I+M versus SOC in patients with BCG-naive ...
Pfizer's Sasanlimab Combination Significantly Improves ...
Pivotal Phase 3 CREST trial results show a 32% reduction in the risk of disease-related events, including high-grade disease recurrence or progression, ...
A Study to Learn About the Study Medicine PF-08052667 ...
* Part 2 (combination dose escalation) will test PF-08052667 in combination with BCG and/or sasanlimab (fixed dose) in participants with certain bladder cancer ...
7.
pfizer.com
pfizer.com/news/press-release/press-release-detail/pfizers-sasanlimab-combination-bcg-improves-event-freePfizer's Sasanlimab in Combination with BCG Improves ...
“Patients with BCG-naïve high-risk non-muscle invasive bladder cancer have high rates of recurrence and progression,” said Neal Shore, M.D., ...
ESMO 2025: Immune-Mediated Adverse Events (imAEs ...
Sasanlimab in combination with BCG showed a safety profile consistent with both the anti-PD-1/PD-L1 drug class and BCG. No increased risk of ...
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