Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
185
Countries
5
Sites
5
Melanoma (or) malignant melanoma Non-small cell lung cancer Head and neck squamous cell carcinoma Esophageal cancer
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
- 23 Jun 2025 → 23 Feb 2026
- Decision date (initial)
- 2025-05-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Melanoma (or) malignant melanoma Non-small cell lung cancer Head and neck squamous cell carcinoma Esophageal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10025650 | Malignant melanoma | 100000004864 |
| 21.0 | LLT | 10015362 | Esophageal cancer | 10029104 |
| 26.1 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
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
5 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 13 | 1 |
| Germany | Ended | 12 | 1 |
| Netherlands | Ended | 7 | 1 |
| Spain | Ended | 13 | 1 |
| Sweden | Ended | 13 | 1 |
| Rest of world
United States, United Kingdom
|
— | 127 | — |
Investigational sites
Institut Gustave Roussy
Département d’innovation Thérapeutique et des Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Charite Universitaetsmedizin Berlin KöR
Haematology- Oncology, Hindenburgdamm 30, Lichterfelde, Berlin
Netherlands Cancer Institute
Clinical Research Unit, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2025-07-07 | 2025-10-07 | 2025-07-18 | 2025-08-15 | |
| Spain | 2025-07-11 | 2025-10-20 | 2025-08-13 | 2025-08-15 | |
| Sweden | 2025-06-23 | 2025-07-30 | 2025-08-15 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-29 | Sweden | Acceptable with conditions 2025-05-19
|
2025-05-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-27 | Acceptable with conditions | 2025-06-06 |