Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
420
Countries
2
Sites
9
Unresectable or metastatic cutaneous squamous cell carcinoma
Key facts
- Sponsor
- Checkpoint Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Sep 2020 → ongoing
- Decision date (initial)
- 2024-09-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517536-22-00
- EudraCT number
- 2018-001463-23
- ClinicalTrials.gov
- NCT03212404
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Unresectable or metastatic cutaneous squamous cell carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041834 | Squamous cell carcinoma of skin | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Checkpoint Therapeutics Inc.
- Sponsor organisation
- Checkpoint Therapeutics Inc.
- Address
- 95 Sawyer Road Suite 110
- City
- Waltham
- Postcode
- 02453-3471
- Country
- United States
Scientific contact point
- Organisation
- Checkpoint Therapeutics Inc.
- Contact name
- Pivotal S.L.U Medical Department
Public contact point
- Organisation
- Checkpoint Therapeutics Inc.
- Contact name
- Information and General Inquires
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 34 | 5 |
| Spain | Ongoing, recruitment ended | 29 | 4 |
| Rest of world
Thailand, Russian Federation, Ukraine, New Zealand, South Africa, Australia
|
— | 357 | — |
Investigational sites
Centre Hospitalier Universitaire De Nice
Onco-Dermatology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Bordeaux
Onco-Dermatology, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Centre Hospitalier Universitaire Grenoble Alpes
Onco-Dermatology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Nantes
Onco-Dermatology, 1 Place Alexis Ricordeau, 44000, Nantes
CHU Besancon
Onco-Dermatology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
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 | 2020-09-29 | 2020-11-06 | 2023-12-04 | ||
| Spain | 2020-09-22 | 2020-11-04 | 2023-12-04 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | Spain | Acceptable with conditions 2024-09-24
|
2024-09-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-11 | Acceptable with conditions | 2024-11-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-27 | Spain | Acceptable 2025-08-13
|
2025-08-14 |