Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07206225 | A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer | PHASE1 | RECRUITING | 294 | — | — | Nov 6, 2025 | Jan 28, 2033 | Apr 21, 2026 | 47 | United States, France +3 |
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...