A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07225570 EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PARTICIPANTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER
First-in-Human Study of PF-07225570 Alone or in Combination with Sasanlimab for Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)
Sponsor: Pfizer
Enrolling: Male and Female Patients
IRB Number: AAAU0209
U.S. Govt. ID: NCT05259397
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This is a Phase 1 study (the first time this treatment is being tested in humans) of an anti-cancer study drug called as PF-07225570. This study drug works on stimulating certain cells in the immune system. The study will test different doses that increase (dose escalation) and at the appropriate time, additional patients will be enrolled to evaluate this treatment in more patients (dose expansion). This study will help to understand the safety of this treatment in humans. The study will help to understand how humans tolerate the treatment as well as how the human body absorbs, metabolizes, and excretes the study drug(s). In addition, the study will help to understand how non-muscle invasive bladder cancer (NMIBC) responds to treatment with the drug we call PF-07225570. NMIBC is a type of bladder cancer that has not spread into the bladder muscle. The study will also combine PF-07225570 and Sasanlimab, an anti-cancer drug that is an antibody (called an anti-PD-1 antibody). This is a type of drug that blocks proteins called checkpoints that are made by some types of immune system cells, such as T cells, and some cancer cells. Sasanlimab and PF-07225570 are not FDA approved.
This study is closed
Investigator
Joel DeCastro, MD, MPH
Do You Qualify?
Are you at least 18 years old? Yes No
Have you been diagnosed with non-muscle invasive bladder cancer (NMIBC)? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162