Clinical trial · Interventional
PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pfizer has decided to terminate Study C4661001 due to strategic considerations. This decision is not due to any specific safety reasons or requests from any regulatory authorities. No participants have been enrolled in this study.
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of PF-07225570 alone or in combination with an anti-PD-1 antibody in participants with recurrent non-muscle invasive bladder cancer. This study consists of 2 parts, single agent dose escalation (Part 1A), dose finding of PF-07225570 in combination with anti-PD-1 antibody (Part 1B) and dose expansion (Part 2).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-07225570 | Drug | — | UNRESOLVED |
| sasanlimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1A PF-07225570 monotherapy
- description
- Intravesical (IVe) Single Agent Dose Escalation
- interventionNames
- Drug: PF-07225570
- type
- EXPERIMENTAL
- label
- Part 1B PF-07225570 and sasanlimab
- description
- PF-07225570 IVe and sasanlimab Subcutaneous (SQ) Combination Dose Escalation
- interventionNames
- Drug: PF-07225570
- Drug: sasanlimab
- type
- EXPERIMENTAL
- label
- Part 2A PF-07225570 monotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histological confirmed and documented diagnosis of non-muscle invasive urothelial carcinoma Participants with recurrent non-muscle invasive bladder cancer (intermediate risk or high risk) Ineligible for or elected not to undergo radical cystectomy No evidence of upper tract urothelial cancer or cancer within the prostatic urethra as documented by imaging studies performed within 6 months of enrollment Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Adequate bone marrow, renal and liver function Exclusion Criteria: Evidence of muscle-invasive, locally advanced or metastatic urothelial carcinoma or concurrent extravesical, non-muscle invasive urothelial carcinoma Macroscopic hematuria, traumatic catheterization or active urinary tract infection Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness
References
Publications (0)
Data not yet available