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
Find a Clinic Near You
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