Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
222
Countries
2
Sites
5
Non-muscle invasive bladder cancer (NMIBC)
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521756-39-00
- ClinicalTrials.gov
- NCT07206225
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-muscle invasive bladder cancer (NMIBC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10087211 | Non-muscle invasive bladder cancer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 11 | 2 |
| Spain | Ongoing, recruiting | 11 | 3 |
| Rest of world
United States, Japan, United Kingdom, Israel, China, Korea, Republic of
|
— | 200 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-04-24 | ||||
| Spain | 2026-04-09 | 2026-05-08 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-23 | Spain | Acceptable with conditions 2026-02-26
|
2026-03-02 |