Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-08052667 · 1 trial · 1 indication
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.
AEs as characterized by type, frequency, severity (CTCAE v5.0), seriousness, and relatedness to study drug(s).
Laboratory abnormalities as characterized by type, frequency, severity
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
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
| Arm | Type | Description |
|---|---|---|
| Monotherapy Dose Escalation | EXPERIMENTAL | 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. |
| Combination Therapy Dose Escalation | EXPERIMENTAL | PF-08052667 + BCG and/or sasanlimab of a 21-day cycle starting from Day 1 |
| Dose Optimization and Expansion | EXPERIMENTAL | PF-08052667 monotherapy or in combination with BCG and/or sasanlimab at dose levels/schedules for PF-08052667 determined in Parts 1 and 2. |
| Name | Type | Description |
|---|---|---|
| PF-08052667 | DRUG | PF-08052667 will be administered intravesical (IVe) instillation following a PF-02921367 (DDM) bladder pre-wash |
| Sasanlimab | DRUG | Sasanlimab will be administered as subcutaneous (SC) injection |
| BCG | DRUG | BCG will be administered intravesical (IVe) instillation |
| PF-02921367 | DRUG | PF-02921367 (DDM) is a 10-min pre- wash and will be administered intravesical (IVe) instillation |
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...
PF-08052667 is an investigational small molecule being developed for the treatment of non-muscle invasive bladder cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a clinical trial enrolling patients with this condition.
PF-08052667 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with non-muscle invasive bladder cancer.
PF-08052667 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The ongoing Phase 1 trial is currently recruiting participants with non-muscle invasive bladder cancer.
PF-08052667 is being studied in a Phase 1 clinical trial with the identifier NCT07206225, titled "A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer." The trial is recruiting participants in the United States, France, Israel, South Korea, Spain, and the United Kingdom, with a planned enrollment of 294 patients.
PF-08052667 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for non-muscle invasive bladder cancer. The drug is being evaluated in a clinical trial that is still recruiting participants, and it has not yet completed the clinical development process required for regulatory approval.